FDAClass IIFebruary 21, 2018

A.T.S. 2200TS Tourniquet Systems recall

A.T.S. 2200TS Tourniquet Systems, Personalized Pressure. Zimmer Surgical, Inc. Dover, OH 44622 Intended to be used by qualified professionals to…

Why was A.T.S. 2200TS Tourniquet Systems recalled?

Updated on-device label and 3 pages of an updated Operator/Service Manual. Also, decrease from 3.8 meters (m) to 1.0 separation distance between the device and RF communication equipment.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot No. Item No. 60400040400, Lot No. 62510548 (Serial Numbers: 2213JAAA, 2213JAAB, 2213JAAC, 2213JAAD, 2213JAAE, 2213JAAF, 2213JAAG, 2213JAAH, 2213JAAJ, 2213JAAK, 2213JAAL, 2213JAAM, 2213JAAN, 2213JAAP, 2213JAAQ, 2213JAAR, 2213JAAS, 2213JAAT, 2213JAAU, 2213JAAW, 2213JABA, 2213JABB, 2213JABC, 2213JABD, 2213JABE, 2213JABF, 2213JABG, 2213JABH); Lot No. 62534445 (Serial Numbers: 2213JABJ, 2213JABK, 2213JABL, 2213JABM, 2213JABN, 2213JABP, 2213JABQ, 2213JABR, 2213JABS, 2213JABT, 2213JABU, 2213JABW, 2213JACA, 2213JACB, 2213JACC, 2213JACD, 2213JACE, 2213JACF, 2213JACG, 2213JACH); Lot No. 62631977 (Serial Numbers: 2214BAAA, 2214BAAB, 2214BAAC, 2214BAAD, 2214BAAE, 2214BAAF, 2214BAAG, 2214BAAH, 2214BAAJ, 2214BAAK, 2214BAAL, 2214BAAM, 2214BAAN, 2214BAAP, 2214BAAQ, 2214BAAR, 2214BAAS, 2214BAAT, 2214BAAU, 2214BAAW); Lot No. 62625059 (Serial Numbers: 2214BABA, 2214BABB, 2214BABC, 2214BABD, 2214BABE, 2214BABF, 2214BABG, 2214BABH, 2214BABJ, 2214BABK, 2214BABL, 2214BABM, 2214BABN, 2214BABP, 2214BABQ, 2214BABR, 2214BABS, 2214BABT, 2214BABU, 2214BABW); Lot No. 62635789 (Serial Numbers: 2214CAAA, 2214CAAB, 2214CAAC, 2214CAAD, 2214CAAE, 2214CAAF, 2214CAAG, 2214CAAH, 2214CAAJ, 2214CAAK, 2214CAAL, 2214CAAM, 2214CAAV, 2214CAAP, 2214CAAQ, 2214CAAR, 2214CAAS, 2214CAAT, 2214CAAU, 2214CAAW); Lot No. 62642067 (Serial Numbers: 2214DAAA, 2214DAAB, 2214DAAC, 2214DAAD, 2214DAAE, 2214DAAF, 2214DAAG, 2214DAAH, 2214DAAJ, 2214DAAK, 2214DAAL, 2214DAAM, 2214DAAN, 2214DAAP, 2214DAAQ, 2214DAAR, 2214DAAS, 2214DAAT, 2214DAAU, 2214DAAW); Lot No. 62642068 (Serial Numbers: 2214EAAA, 2214EAAB, 2214EAAC, 2214EAAD, 2014EAAE, 2214EAAF, 2214EAAG, 2214EAAH, 2214EAAJ, 2214EAAK, 2214EAAL, 2214EAAM, 2214EAAN, 2214EAAP, 2214EAAQ, 2214EAAR, 2214EAAS, 2214EAAT, 2214EAAU, 2214EAAW); Lot No. 62675190 (Serial Numbers: 2214DABA); Lot No. 62732714 (Serial Numbers: 2214FAAA, 2214FAAB, 2214FAAC, 2214FAAD); Lot No. 62727347 (Serial Numbers: 2214FAAE, 2214FAAF, 2214FAAG, 2214FAAH); Lot No. 62727348 (Serial Numbers: 2214FAAJ, 2214FAAK, 2214FAAL); Lot No. 62745916 (Serial Numbers: 2214FAAM, 2214FAAN); Lot No. 62723747 (Serial Numbers: 2214FAAP, 2214FAAQ, 2214FAAR, 2214FAAS, 2214FAAT, 2214FAAU, 2214FAAW, 2214FABA, 2214FABB, 2214FABC, 2214FABD, 2214FABE, 2214FABF, 2214FABG, 2214FABH, 2214FABJ, 2214FABK, 2214FABL, 2214FABM, 2214FABN); Lot No. 62723748 (Serial Numbers: 2214FABP, 2214FABQ, 2214FABR, 2214FABS, 2214FABT, 2214FABU, 2214FABW, 2214FACA, 2214FACB, 2214FACC, 2214FACD, 2214FACE, 2214FACF, 2214FACG, 2214FACH, 2214FACJ, 2214FACK, 2214FACL, 2214FACM, 2214FACN); Lot No. 62758708 (Serial Numbers: 2214GAAA, 2214GAAB, 2214GAAC, 2214GAAD); Lot No. 62758711 (Serial Numbers: 2214GAAE); Lot No. 62760907 (Serial Numbers: 2214GAAF, 2214GAAG); Lot No. 63773338 (Serial Numbers: 2214GAAH, 2214GAAJ, 2214GAAK, 2214GAAL); Lot No. 62773820 (Serial Numbers: 2214GAAM, 2214GAAN); Lot No. 62773463 (Serial Numbers: 2214GAAP); Lot No. 62773471 (Serial Numbers: 2214GAAQ, 2214GAAR, 2214GAAS); Lot No. 62773478 (Serial Numbers: 2214GAAT, 2214GAAU, 2214GAAW, 2214GABA); Lot No. 62773485 (Serial Numbers: 2214GABB, 2214GABC); Lot No. 62748403 (Serial Numbers: 2214GABD, 2214GABE, 2214GABF, 2214GABG, 2214GABH, 2214GABJ, 2214GABK, 2214GABL, 2214GABM, 2214GABN, 2214GABP, 2214GABQ, 2214GABR, 2214GABS, 2214GABT, 2214GABU, 2214GABW, 2214GACA, 2214GACB, 2214GACC); Lot No. 62779664 (Serial Numbers: 2214GACD, 2214GACE); Lot No. 62797832 (Serial Numbers: 2214HAAA, 2214HAAB, 2214HAAC); Lot No. 62797833 (Serial Numbers: 2214HAAD, 2214HAAE, 2214HAAF, 2214HAAG, 2214HAAH); Lot No. 62799449 (Serial Numbers: 2214HAAJ, 2214HAAK, 2214HAAL, 2214HAAM, 2214HAAN, 2214HAAP, 2214HAAQ, 2214HAAR, 2214HAAS, 2214HAAT, 2214HAAU, 2214HAAW, 2214HABA, 2214HABB, 2214HABC, 2214HABD, 2214HABE, 2214HABF, 2214HABG, 2214HABH); Lot No. 62799475 (Serial Numbers: 2214HABJ, 2214HABK, 2214HABL, 2214HABM, 2214HABN, 2214HABP, 2214HABQ, 2214HABR, 2214HABS, 2214HABT, 2214HABU, 2214HABW, 2214HACA, 2214HACB, 2214HACC, 2214HACD, 2214HACE, 2214HACF, 2214HACG, 2214HACH); Lot No. 62824836 (Serial Numbers: 2214IAAA, 2214IAAB, 2214IAAC, 2214IAAD); Lot No. 62838042 (Serial Numbers: 2214IAAE, 2214IAAF, 2214IAAG, 2214IAAH); Lot No. 62812885 (Serial Numbers: 2214IAAJ, 2214IAAK, 2214IAAL, 2214IAAM, 2214IAAN, 2214IAAP, 2214IAAQ, 2214IAAR, 2214IAAS, 2214IAAT, 2214IAAU, 2214IAAW, 2214IABA, 2214IABB, 2214IABC, 2214IABD, 2214IABE, 2214IABF, 2214IABG, 2214IABH); Lot No. 62812853 (Serial Numbers: 2214IABJ, 2214IABK, 2214IABL, 2214IABM, 2214IABN, 2214IABP, 2214IABQ, 2214IABR, 2214IABS, 2214IABT, 2214IABU, 2214IABW, 2214IACA, 2214IACB, 2214IACC, 2214IACD, 2214IACE, 2214IACF, 2214IACG, 2214IACH); Lot No. 62846159 (Serial Numbers: 2214JAAA, 2214JAAB, 2214JAAC); Lot No. 62844916 (Serial Numbers: 2214JAAD); Lot No. 62869981 (Serial Numbers: 2214KAAE, 2214KAAF, 2214KAAG, 2214KAAH, 2214KAAJ); Lot No. 62871639 (Serial Numbers: 2214JAAE, 2214JAAF, 2214JAAG, 2214JAAH); Lot No. 62870928 (Serial Numbers: 2214KAAK, 2214KAAL, 2214KAAM, 2214KAAN, 2214KAAP, 2214KAAQ, 2214KAAR, 2214KAAS, 2214KAAT, 2214KAAU, 2214KAAW, 2214KABA, 2214KABB, 2214KABC, 2214KABD, 2214KABE, 2214KABF, 2214KABG, 2214KABH, 2214KABJ); Lot No. 62877932 (Serial Numbers: 221411110001, 221411110002, 221411110003, 221411110004, 221411110005, 221411110006, 221411110007, 221411110008, 221411110009, 221411110010); Lot No. 62885586 (Serial Numbers: 221411120001, 221411120002, 221411120003, 221411120004, 221411120005); Lot No. 62885587 (Serial Numbers: 221411120006, 221411120007, 221411120008, 221411120009, 221411120010, 221411120011, 221411120012, 221411120013, 221411120014, 221411120015); Lot No. 62895898 (Serial Numbers: 221411200001, 221411200002, 221411200003, 221411200004, 221411200005, 221411200006, 221411200007, 221411200008, 221411200009, 221411200010); Lot No. 62905257 (Serial Numbers: 221411240001); Lot No. 62904091 (Serial Numbers: 221411250001, 221411250002, 221411250003, 221411250004, 221411250005, 221411250006, 221411250007, 221411250008, 221411250009, 221411250010, 221411250011, 221411250012, 221411250013, 221411250014, 221411250015, 221411250016, 221411250017, 221411250018, 221411250019, 221411250020); Lot No. 62904093 (Serial Numbers: 221412010001, 221412010002, 221412010003, 221412010004, 221412010005, 221412010006, 221412010007, 221412010008, 221412010009, 221412010010, 221412010011, 221412010012, 221412010013, 221412010014, 221412010015, 221412010016, 221412010017, 221412010018, 221412010019, 221412010020); Lot No. 62879139 (Serial Numbers: 221412040001, 221412040002, 221412040003, 221412040004, 221412040005); Lot No. 62905838 (Serial Numbers: 221412080001, 221412080002, 221412080003, 221412080004, 221412080005); Lot No. 62895896 (Serial Numbers: 221412120001, 221412120002, 221412120003, 221412120004, 221412120005); Lot No. 62904123 (Serial Numbers: 221412150001, 221412150002, 221412150003, 221412150004, 221412150005, 221412150006, 221412150007, 221412150008, 221412150009, 221412150010, 221412150011, 221412150012, 221412150013, 221412150014, 221412150015, 221412150016, 221412150017, 221412150018, 221412150019, 221412150020); Lot No. 62932244 (Serial Numbers: 221412180001, 221412180002, 221412180003, 221412180004, 221412180005, 221412180006, 221412180007, 221412180008, 221412180009, 221412180010, 221412180011, 221412180012, 221412180013, 221412180014, 221412180015, 221412180016, 221412180017, 221412180018, 221412180019, 221412180020); Lot No. 62935217 (Serial Numbers: 221412190001, 221412190002, 221412190003, 221412190004, 221412190005); Lot No. 62937693 (Serial Numbers: 221501050001, 221501050002, 221501050003, 221501050004, 221501050005); Lot No. 62945082 (Serial Numbers: 221501080001, 221501080002, 221501080003, 221501080004, 221501080005); Lot No. 62945086 (Serial Numbers: 201501080006, 201501080007, 201501080008); Lot No. 62932650 (Serial Numbers: 221503090001, 221503090002, 221503090003, 221503090004, 221503090005, 221503090006, 221503090007, 221503090008, 221503090009, 221503090010, 221503090011, 221503090012, 221503090013, 221503090014, 221503090015, 221503090016, 221503090017, 221503090018, 221503090019, 22150309002); Lot No. 62961804 (Serial Numbers: 221503120001, 221503120002, 221503120003, 221503120004, 221503120005, 221503120006, 221503120007, 221503120008, 221503120009, 221503120010, 221503120011, 221503120012, 221503120013, 221503120014, 221503120015, 221503120016, 221503120017, 221503120018, 221503120019, 221503120020); Lot No. 62976480 (Serial Numbers: 221503190001, 221503190002, 221503190003, 221503190004, 221503190005, 221503190006, 221503190007, 221503190008, 221503190009, 221503190010, 221503190011, 221503190012, 221503190013, 221503190014, 221503190015, 221503190016, 221503190017, 221503190018, 221503190019, 221503190020); Lot No. 62976481 (Serial Numbers: 221503250001, 221503250002, 221503250003, 221503250004, 221503250005, 221503250006, 221503250007, 221503250008, 221503250009, 221503250010, 221503250011, 221503250012, 221503250013, 221503250014, 221503250015, 221503250016, 221503250017, 221503250018, 221503250019, 221503250020); Lot No. 63026460 (Serial Numbers: 221503270001, 221503270002, 221503270003, 221503270004, 221503270005); Lot No. 63007852 (Serial Numbers: 221504080001, 221504080002, 221504080003, 221504080004, 221504080005, 221504080006, 221504080007, 221504080008, 221504080009, 221504080010, 221504080011, 221504080012, 221504080013, 221504080014, 221504080015, 221504080016, 221504080017, 221504080018, 221504080019, 221504080020 Lot No. 63042181 (Serial Numbers: 221504140001, 221504140002, 221504140003, 221504140004, 221504140005); Lot No. 63042182 (Serial Numbers: 221504140006, 221504140007, 221504140008, 221504140009, 221504140010); Lot No. 63007853 (Serial Numbers: 221504140011, 221504140012, 221504140013, 221504140014, 221504140015, 221504140016, 221504140017, 221504140018, 221504140019, 221504140020, 221504140021, 221504140022, 221504140023, 221504140024, 221504140025, 221504140026, 221504140027, 221504140028, 221504140029, 221504140030); Lot No. 63042179 (Serial Numbers: 221504160001, 221504160002, 221504160003); Lot No. 63042184 (Serial Numbers: 221504220001, 221504220002, 221504220003, 221504220004, 221504220005); Lot No. 63037252 (Serial Numbers: 221504250001, 221504250002, 221504250003, 221504250004, 221504250005, 221504250006, 221504250007, 221504250008, 221504250009, 221504250010, 221504250011, 221504250012, 221504250013, 221504250014, 221504250015, 221504250016, 221504250017, 221504250018, 221504250019, 221504250020); Lot No. 63042180 (Serial Numbers: 221504280001, 221504280002, 221504280003, 221504280004, 221504280005, 221504280006, 221504280007, 221504280008, 221504280009, 221504280010, 221504280011, 221504280012, 221504280013, 221504280014, 221504280015, 221504280016, 221504280017, 221504280018, 221504280019, 221504280020); Lot No. 63042183 (Serial Numbers: 221505110001, 221505110002, 221505110003, 221505110004, 221505110005); Lot No. 63037254 (Serial Numbers: 221505120001, 221505120002, 221505120003, 221505120004, 221505120005, 221505120006, 221505120007, 221505120008, 221505120009, 221505120010, 221505120011, 221505120012, 221505120013, 221505120014, 221505120015, 221505120016, 221505120017, 221505120018, 221505120019, 221505120020); Lot No. 63092209 (Serial Numbers: 221506030001, 221506030002, 221506030003); Lot No. 63092210 (Serial Numbers: 221506050001, 221506050002, 221506050003, 221506050004, 221506050005); Lot No. 63072301 (Serial Numbers: 221506100001, 221506100002, 221506100003, 221506100004, 221506100005, 221506100006, 221506100007, 221506100008, 221506100009, 221506100010, 221506100011, 221506100012, 221506100013, 221506100014, 221506100015, 221506100016, 221506100017, 221506100018, 221506100019, 221506100020); Lot No. 63103587 (Serial Numbers: 221506130001, 221506130002, 221506130003, 221506130004, 221506130005, 221506130006, 221506130007, 221506130008, 221506130009, 221506130010, 221506130011, 221506130012, 221506130013, 221506130014, 221506130015); Lot No. 63072324 (Serial Numbers: 221506170001, 221506170002, 221506170003, 221506170004, 221506170005, 221506170006, 221506170007, 221506170008, 221506170009, 221506170010, 221506170011, 221506170012, 221506170013, 221506170014, 221506170015, 221506170016, 221506170017, 221506170018, 221506170019, 221506170020); Lot No. 63103164 (Serial Numbers: 221506170021, 221506170022, 221506170023); Lot No. 63072352 (Serial Numbers: 221506200001, 221506200002, 221506200003, 221506200004, 221506200005, 221506200006, 221506200007, 221506200008, 221506200009, 221506200010, 221506200011, 221506200012, 221506200013, 221506200014, 221506200015, 221506200016, 221506200017, 221506200018, 221506200019, 221506200020); Lot No. 63096468 (Serial Numbers: 221507150001, 221507150002, 221507150003, 221507150004, 221507150005, 221507150006, 221507150007, 221507150008, 221507150009, 221507150010, 221507150011, 221507150012, 221507150013, 221507150014, 221507150015, 221507150016, 221507150017, 221507150018, 221507150019, 221507150020); Lot No. 63109655 (Serial Numbers: 221507160001, 221507160002, 221507160003); Lot No. 63103590 (Serial Numbers: 221507210001, 221507210002, 221507210003, 221507210004, 221507210005, 221507210006, 221507210007, 221507210008, 221507210009, 221507210010, 221507210011, 221507210012, 221507210013, 221507210014, 221507210015); Lot No. 63109651 (Serial Numbers: 221507280001, 221507280002, 221507280003, 221507280004, 221507280005, 221507280006, 221507280007, 221507280008, 221507280009, 221507280010); Lot No. 63116357 (Serial Numbers: 221507290001, 221507290002, 221507290003, 221507290004, 221507290005, 221507290006, 221507290007, 221507290008, 221507290009, 221507290010, 221507290011, 221507290012, 221507290013, 221507290014, 221507290015, 221507290016, 221507290017, 221507290018, 221507290019, 221507290020); Lot No. 63123305 (Serial Numbers: 221508040001, 221508040002, 221508040003, 221508040004, 221508040005, 221508040006, 221508040007, 221508040008, 221508040009, 221508040010, 221508040011, 221508040012, 221508040013, 221508040014, 221508040015, 221508040016, 221508040017, 221508040018, 221508040019, 221508040020); Lot No. 63138553 (Serial Numbers: 221508260001, 221508260002, 221508260003, 221508260004, 221508260005, 221508260006, 221508260007, 221508260008, 221508260009, 221508260010, 221508260011, 221508260012, 221508260013, 221508260014, 221508260015, 221508260016, 221508260017, 221508260018, 221508260019, 221508260020); Lot No. 63138631 (Serial Numbers: 221509090001, 221509090002, 221509090003, 221509090004, 221509090005, 221509090006, 221509090007, 221509090008, 221509090009, 221509090010, 221509090011, 221509090012, 221509090013, 221509090014, 221509090015, 221509090016, 221509090017, 221509090018, 221509090019, 221509090020); Lot No. 63171089 (Serial Numbers: 221509240001, 221509240002, 221509240003, 221509240004, 221509240005, 221509240006, 221509240007, 221509240008, 221509240009, 221509240010, 221509240011, 221509240012, 221509240013, 221509240014, 221509240015, 221509240016, 221509240017, 221509240018, 221509240019, 221509240020); Lot No. 63202480 (Serial Numbers: 221510120001, 221510120002, 221510120003, 221510120004, 221510120005); Lot No. 63202478 (Serial Numbers: 221510220001, 221510220002, 221510220003, 221510220004, 221510220005, 221510220006, 221510220007, 221510220008, 221510220009, 221510220010, 221510220011, 221510220012, 221510220013, 221510220014, 221510220015, 221510220016, 221510220017, 221510220018, 221510220019, 221510220020); Lot No. 63234563 (Serial Numbers: 221511230001, 221511230002, 221511230003, 221511230004, 221511230005); Lot No. 63234565 (Serial Numbers: 221512020001, 221512020002, 221512020003, 221512020004, 221512020005); Lot No. 63212407 (Serial Numbers: 221512070001, 221512070002, 221512070003, 221512070004, 221512070005, 221512070006, 221512070007, 221512070008, 221512070009, 221512070010, 221512070011, 221512070012, 221512070013, 221512070014, 221512070015, 221512070016, 221512070017, 221512070018, 221512070019, 221512070020); Lot No. 63245752 (Serial Numbers: 221512160001, 221512160002, 221512160003, 221512160004, 221512160005, 221512160006, 221512160007); Lot No. 63253256 (Serial Numbers: 221512180001, 221512180002, 221512180003, 221512180004, 221512180005); Lot No. 63247425 (Serial Numbers: 221601060001, 221601060002, 221601060003, 221601060004, 221601060005, 221601060006, 221601060007, 221601060008, 221601060009, 221601060010, 221601060011, 221601060012, 221601060013, 221601060014, 221601060015, 221601060016, 221601060017, 221601060018, 221601060019, 221601060020); Lot No. 63526287 (Serial Numbers: 221612140001, 221612140002, 221612140003, 221612140004, 221612140005, 221612140006, 221612140007, 221612140008, 221612140009, 221612140010, 221612140011, 221612140012, 221612140013, 221612140014, 221612140015, 221612140016, 221612140017, 221612140018, 221612140019, 221612140020); Lot No. 63531691 (Serial Numbers: 221612150001, 221612150002, 221612150003, 221612150004, 221612150005, 221612150006, 221612150007); Lot No. 63526321 (Serial Numbers: 221612170001, 221612170002, 221612170003, 221612170004, 221612170005, 221612170006, 221612170007, 221612170008, 221612170009, 221612170010, 221612170011, 221612170012, 221612170013, 221612170014, 221612170015, 221612170016, 221612170017, 221612170018, 221612170019, 221612170020); Lot No. 63261584 (Serial Numbers: 221601070001, 221601070002, 221601070003, 221601070004, 221601070005); Lot No. 63264374 (Serial Numbers: 221601110001, 221601110002, 221601110003, 221601110004, 221601110005, 221601110006, 221601110007, 221601110008, 221601110009, 221601110010, 221601110011, 221601110012, 221601110013, 221601110014, 221601110015, 221601110016, 221601110017, 221601110018, 221601110019, 221601110020); Lot No. 63265280 (Serial Numbers: 221601140001, 221601140002, 221601140003, 221601140004, 221601140005, 221601140006, 221601140007); Lot No. 63257987 (Serial Numbers: 221601180001, 221601180002, 221601180003, 221601180004, 221601180005, 221601180006, 221601180007, 221601180008, 221601180009, 221601180010, 221601180011, 221601180012, 221601180013, 221601180014, 221601180015, 221601180016, 221601180017, 221601180018, 221601180019, 221601180020); Lot No. 63271202 (Serial Numbers: 221601220001, 221601220002, 221601220003, 221601220004, 221601220005); Lot No. 63258039 (Serial Numbers: 221602060001, 221602060002, 221602060003, 221602060004, 221602060005, 221602060006, 221602060007, 221602060008, 221602060009, 221602060010, 221602060011, 221602060012, 221602060013, 221602060014, 221602060015, 221602060016, 221602060017, 221602060018, 221602060019, 221602060020); Lot No. 63278388 (Serial Numbers: 221602150001, 221602150002, 221602150003, 221602150004, 221602150005, 221602150006, 221602150007, 221602150008, 221602150009, 221602150010, 221602150011, 221602150012, 221602150013, 221602150014, 221602150015, 221602150016, 221602150017, 221602150018, 221602150019, 221602150020); Lot No. 63278436 (Serial Numbers: 221602240001, 221602240002, 221602240003, 221602240004, 221602240005, 221602240006, 221602240007, 221602240008, 221602240009, 221602240010, 221602240011, 221602240012, 221602240013, 221602240014, 221602240015, 221602240016, 221602240017, 221602240018, 221602240019, 221602240020); Lot No. 63314121 (Serial Numbers: 221603090001, 221603090002, 221603090003); Lot No. 63314118 (Serial Numbers: 221603110001, 221603110002, 221603110003); Lot No. 63324625 (Serial Numbers: 221603220001, 221603220002, 221603220003); Lot No. 63336959 (Serial Numbers: 221603300001, 221603300002, 221603300003, 221603300004, 221603300005, 221603300006, 221603300007, 221603300008, 221603300009, 221603300010); Lot No. 63314042 (Serial Numbers: 221603300011, 221603300012, 221603300013, 221603300014, 221603300015, 221603300016, 221603300017, 221603300018, 221603300019, 221603300020, 221603300021, 221603300022, 221603300023, 221603300024, 221603300025, 221603300026, 221603300027, 221603300028, 221603300029, 221603300030); Lot No. 63341344 (Serial Numbers: 221604040001, 221604040002, 221604040003, 221604040004, 221604040005); Lot No. 63341346 (Serial Numbers: 221604050001, 221604050002, 221604050003, 221604050004, 221604050005, 221604050006, 221604050007, 221604050008, 221604050009, 221604050010); Lot No. 63314117 (Serial Numbers: 221604220001, 221604220002, 221604220003, 221604220004, 221604220005, 221604220006, 221604220007, 221604220008, 221604220009, 221604220010, 221604220011, 221604220012, 221604220013, 221604220014, 221604220015, 221604220016, 221604220017, 221604220018, 221604220019, 221604220020); Lot No. 63352349 (Serial Numbers: 221604250001, 221604250002, 221604250003); Lot No. 63339440 (Serial Numbers: 221605020001, 221605020002, 221605020003, 221605020004, 221605020005, 221605020006, 221605020007, 221605020008, 221605020009, 221605020010, 221605020011, 221605020012, 221605020013, 221605020014, 221605020015, 221605020016, 221605020017, 221605020018, 221605020019, 221605020020); Lot No. 63343366 (Serial Numbers: 221605060001, 221605060002, 221605060003, 221605060004, 221605060005, 221605060006, 221605060007, 221605060008, 221605060009, 221605060010, 221605060011, 221605060012, 221605060013, 221605060014, 221605060015, 221605060016, 221605060017, 221605060018, 221605060019, 221605060020, 221605060021, 221605060022); Lot No. 63352347 (Serial Numbers: 221605110001, 221605110002, 221605110003, 221605110004, 221605110005); Lot No. 63339497 (Serial Numbers: 221605120001, 221605120002, 221605120003, 221605120004, 221605120005, 221605120006, 221605120007, 221605120008, 221605120009, 221605120010, 221605120011, 221605120012, 221605120013, 221605120014, 221605120015, 221605120016, 221605120017, 221605120018, 221605120019, 221605120020); Lot No. 63378855 (Serial Numbers: 221606020001, 221606020002, 221606020003); Lot No. 63369605 (Serial Numbers: 221606110001, 221606110002, 221606110003, 221606110004, 221606110005, 221606110006, 221606110007, 221606110008, 221606110009, 221606110010, 221606110011, 221606110012, 221606110013, 221606110014, 221606110015, 221606110016, 221606110017, 221606110018, 221606110019, 221606110020); Lot No. 63403010 (Serial Numbers: 221606110021, 221606110022, 221606110023); Lot No. 63403012 (Serial Numbers: 221606150001, 221606150002, 221606150003, 221606150004, 221606150005, 221606150006, 221606150007, 221606150008); Lot No. 63403026 (Serial Numbers: 221606210001, 221606210002, 221606210003, 221606210004, 221606210005, 221606210006, 221606210007, 221606210008, 221606210009, 221606210010, 221606210011, 221606210012, 221606210013, 221606210014, 221606210015, 221606210016, 221606210017, 221606210018, 221606210019, 221606210020); Lot No. 63403009 (Serial Numbers: 221606220001, 221606220002, 221606220003); Lot No. 63403024 (Serial Numbers: 221606230001, 221606230002, 221606230003, 221606230004, 221606230005, 221606230006, 221606230007, 221606230008, 221606230009, 221606230010, 221606230011, 221606230012, 221606230013, 221606230014, 221606230015, 221606230016, 221606230017, 221606230018, 221606230019, 221606230020); Lot No. 63403025 (Serial Numbers: 221606240001, 221606240002, 221606240003, 221606240004, 221606240005, 221606240006, 221606240007, 221606240008, 221606240009, 221606240010); Lot No. 63403017 (Serial Numbers: 221606240011, 221606240012, 221606240013, 221606240014, 221606240015); Lot No. 63394148 (Serial Numbers: 221606290001, 221606290002, 221606290003, 221606290004, 221606290005, 221606290006, 221606290007, 221606290008, 221606290009, 221606290010, 221606290011, 221606290012, 221606290013, 221606290014, 221606290015, 221606290016, 221606290017, 221606290018, 221606290019, 221606290020); Lot No. 63410582 (Serial Numbers: 221607050001, 221607050002, 221607050003, 221607050004, 221607050005, 221607050006, 221607050007, 221607050008, 221607050009, 221607050010, 221607050011, 221607050012, 221607050013, 221607050014, 221607050015); Lot No. 63422767 (Serial Numbers: 221607080001, 221607080002, 221607080003, 221607080004, 221607080005, 221607080006, 221607080007, 221607080008, 221607080009, 221607080010, 221607080011, 221607080012, 221607080013, 221607080014, 221607080015, 221607080016, 221607080017, 221607080018, 221607080019, 221607080020); Lot No. 63410583 (Serial Numbers: 221607210001, 221607210002, 221607210003, 221607210004, 221607210005, 221607210006, 221607210007, 221607210008, 221607210009, 221607210010); Lot No. 63410585 (Serial Numbers: 221607220001, 221607220002, 221607220003, 221607220004, 221607220005, 221607220006, 221607220007, 221607220008, 221607220009, 221607220010); Lot No. 63394176 (Serial Numbers: 221607260001, 221607260002, 221607260003, 221607260004, 221607260005, 221607260006, 221607260007, 221607260008, 221607260009, 221607260010, 221607260011, 221607260012, 221607260013, 221607260014, 221607260015, 221607260016, 221607260017, 221607260018, 221607260019, 221607260020); Lot No. 63430499 (Serial Numbers: 221608080001, 221608080002, 221608080003, 221608080004, 221608080005, 221608080006, 221608080007, 221608080008, 221608080009, 221608080010, 221608080011, 221608080012, 221608080013, 221608080014, 221608080015, 221608080016, 221608080017, 221608080018, 221608080019, 221608080020); Lot No. 63437710 (Serial Numbers: 221608120001, 221608120002, 221608120003, 221608120004, 221608120005); Lot No. 63436338 (Serial Numbers: 221608160001, 221608160002, 221608160003, 221608160004, 221608160005); Lot No. 63445193 (Serial Numbers: 221608170001, 221608170002, 221608170003, 221608170004, 221608170005, 221608170006, 221608170007, 221608170008, 221608170009, 221608170010, 221608170011, 221608170012, 221608170013, 221608170014, 221608170015, 221608170016, 221608170017, 221608170018, 221608170019, 221608170020); Lot No. 63430540 (Serial Numbers: 221608190001, 221608190002, 221608190003, 221608190004, 221608190005, 221608190006, 221608190007, 221608190008, 221608190009, 221608190010, 221608190011, 221608190012, 221608190013, 221608190014, 221608190015, 221608190016, 221608190017, 221608190018, 221608190019, 221608190020); Lot No. 63445194 (Serial Numbers: 221608230001, 221608230002, 221608230003, 221608230004, 221608230005, 221608230006, 221608230007, 221608230008, 221608230009, 221608230010, 221608230011, 221608230012, 221608230013, 221608230014, 221608230015, 221608230016, 221608230017, 221608230018, 221608230019, 221608230020); Lot No. 63455066 (Serial Numbers: 221609010001, 221609010002, 221609010003, 221609010004, 221609010005, 221609010006, 221609010007, 221609010008, 221609010009, 221609010010, 221609010011, 221609010012, 221609010013, 221609010014, 221609010015, 221609010016, 221609010017, 221609010018, 221609010019, 221609010020); Lot No. 63474281 (Serial Numbers: 221609080001, 221609080002, 221609080003, 221609080004, 221609080005, 221609080006, 221609080007, 221609080008, 221609080009, 221609080010, 221609080011, 221609080012, 221609080013, 221609080014, 221609080015, 221609080016, 221609080017, 221609080018, 221609080019, 221609080020); Lot No. 63474283 (Serial Numbers: 221609080021, 221609080022, 221609080023, 221609080024, 221609080025, 221609080026); Lot No. 63474284 (Serial Numbers: 221609150001, 221609150002, 221609150003, 221609150004, 221609150005, 221609150006, 221609150007, 221609150008); Lot No. 63474287 (Serial Numbers: 221609210001, 221609210002, 221609210003, 221609210004, 221609210005, 221609210006, 221609210007, 221609210008, 221609210009, 221609210010); Lot No. 63474285 (Serial Numbers: 221610010001, 221610010002, 221610010003, 221610010004, 221610010005, 221610010006, 221610010007, 221610010008, 221610010009, 221610010010, 221610010011, 221610010012, 221610010013, 221610010014, 221610010015); Lot No. 63455098 (Serial Numbers: 221610050001, 221610050002, 221610050003, 221610050004, 221610050005, 221610050006, 221610050007, 221610050008, 221610050009, 221610050010, 221610050011, 221610050012, 221610050013, 221610050014, 221610050015, 221610050016, 221610050017, 221610050018, 221610050019, 221610050020); Lot No. 63474282 (Serial Numbers: 221610110001, 221610110002, 221610110003, 221610110004, 221610110005, 221610110006, 221610110007, 221610110008, 221610110009, 221610110010, 221610110011, 221610110012, 221610110013, 221610110014, 221610110015, 221610110016, 221610110017, 221610110018, 221610110019, 221610110020); Lot No. 63484747 (Serial Numbers: 221610140001, 221610140002, 221610140003, 221610140004, 221610140005); Lot No. 63482404 (Serial Numbers: 221610180001, 221610180002, 221610180003, 221610180004, 221610180005, 221610180006, 221610180007, 221610180008, 221610180009, 221610180010, 221610180011, 221610180012, 221610180013, 221610180014, 221610180015, 221610180016, 221610180017, 221610180018, 221610180019, 221610180020); Lot No. 63482405 (Serial Numbers: 221610200001, 221610200002, 221610200003, 221610200004, 221610200005, 221610200006, 221610200007, 221610200008, 221610200009, 221610200010, 221610200011, 221610200012, 221610200013, 221610200014, 221610200015, 221610200016, 221610200017, 221610200018, 221610200019, 221610200020); Lot No. 63482408 (Serial Numbers: 221611210001, 221611210002, 221611210003, 221611210004, 221611210005, 221611210006, 221611210007, 221611210008, 221611210009, 221611210010, 221611210011,221611210012, 221611210013, 221611210014, 221611210015, 221611210016, 221611210017, 221611210018, 221611210019, 221611210020); Lot No. 63501470 (Serial Numbers: 221611210021, 221611210022, 221611210023, 221611210024, 221611210025); Lot No. 63501471 (Serial Numbers: 221611210021, 221611210022, 221611210023, 221611210024, 221611210025); Lot No. 63501459 (Serial Numbers: 221611280001, 221611280002, 221611280003, 221611280004, 221611280005, 221611280006, 221611280007, 221611280008, 221611280009, 221611280010, 221611280011, 221611280012, 221611280013, 221611280014, 221611280015, 221611280016, 221611280017, 221611280018, 221611280019, 221611280020); Lot No. 63501486 (Serial Numbers: 221612020001, 221612020002, 221612020003, 221612020004, 221612020005, 221612020006, 221612020007, 221612020008, 221612020009, 221612020010, 221612020011, 221612020012, 221612020013, 221612020014, 221612020015, 221612020016, 221612020017, 221612020018, 221612020019, 221612020020); Lot No. 63501469 (Serial Numbers: 221612030001, 221612030002, 221612030003, 221612030004, 221612030005, 221612030006, 221612030007, 221612030008, 221612030009, 221612030010, 221612030011, 221612030012, 221612030013, 221612030014, 221612030015, 221612030016, 221612030017, 221612030018); Lot No. 63531693 (Serial Numbers: 221612050001, 221612050002, 221612050003, 221612050004, 221612050005); Lot No. 63501509 (Serial Numbers: 221612070001, 221612070002, 221612070003, 221612070004, 221612070005, 221612070006, 221612070007, 221612070008, 221612070009, 221612070010, 221612070011, 221612070012, 221612070013, 221612070014, 221612070015, 221612070016, 221612070017, 221612070018, 221612070019, 221612070020); Lot No. 63501547 (Serial Numbers: 221612100001, 221612100002, 221612100003, 221612100004, 221612100005, 221612100006, 221612100007, 221612100008, 221612100009, 221612100010, 221612100011, 221612100012, 221612100013, 221612100014, 221612100015, 221612100016, 221612100017, 221612100018, 221612100019, 221612100020); Lot No. 63501493 (Serial Numbers: 221612130001, 221612130002, 221612130003, 221612130004, 221612130005, 221612130006, 221612130007, 221612130008)

Product
A.T.S. 2200TS Tourniquet Systems, Personalized Pressure. Zimmer Surgical, Inc. Dover, OH 44622 Intended to be used by qualified professionals to…
Recalling firm
Zimmer Surgical Inc
Quantity
8,231 devices total
Distribution
Worldwide Distribution: US (nationwide) to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, including Guam; and countries to Australia, Brazil, Canada, Chile, China, Denmark, Dominican, El Salvador, England, Finland, France, Hong Kong, India, Italy, Japan, Malaysia, Mexico, Netherlands, Panama, Singapore, Sweden, Taiwan, and Thailand..
Recall date
February 21, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls