AperFix Femoral Implant Coring Removal Drill recall
AperFix Femoral Implant Coring Removal Drill, labeled as the following: a. Femoral Removal Coring Reamer 9mm, Model Number CM-7109; b. Femoral Removal…
Why was AperFix Femoral Implant Coring Removal Drill recalled?
A review of product complaints in 2010 identified a trend for the Coring Removal Drill of premature wear and/or breakage. This recall occurred in 2013.
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?
a. Model Number CM-7109, Lot Codes: 2091004, 3041001, 3151117, 3250806, 3291018, 4191101, 5181012, 6211011, 6270801, 7081012, 7131004, 7231005, 7281004, 7281019, 8161104, 8311131, 8311133, 8311134, 9081004, 9091102, 9141012, 9170902, 9220903, 9220910, 9271002, 10130801, 10140904, 10160901, 10211013, 11091001, 11161022, 11171022, 12030901, 12131001, 12281001, 12290910, 12291008, LNR; b. Model Number CM-7110, Lot Codes: 2091005, 3151118, 3250807, 3291014, 4191102, 4201002, 5181002, 5181009, 6211013, 6270802, 7081013, 7131005, 7231001, 7281005, 7281020, 7311217, 9030903, 9080802, 9081005, 9091103, 9141013, 9161103, 9170903, 9220904, 9220911, 9271003, 10140905, 10160902, 10211001, 11071104, 11091002, 12030902, 12080802, 12131002, 12281002, 12291010, LNR; c. Model Number CM-7111, Lot Codes: 2091006, 3151119, 3250808, 3291017, 4191103, 5181003, 5181013, 6211015, 7081014, 7131006, 7131007, 7140802, 7231006, 7281006, 7281021, 8161103, 8311128, 8311129, 8311130, 8311132, 9081006, 9091104, 9141014, 9220905, 9220912, 10140906, 10160804, 10160903, 10211011, 11091003, 12030903, 12131003, 12291009, LNR; d. Model Number CM-7129, Lot Codes: 1130905, 4211103, 6211012, 7010909, 7081015, 7231010, 7281007, 7281022, 7311214, 8041105, 8060804, 8161102, 8311140, 8311141, 8311142, 9081007, 9091105, 9170904, 9220906, 10211004, 12131004, 12291011, LNR; e. Model Number CM-7130, Lot Codes: 1130906, 3151120, 3291015, 5181010, 6211014, 7010910, 7081016, 7231007, 7281008, 7281023, 7311215, 8041106, 8060803, 8311135, 9081008, 9091106, 9170905, 9220907, 10211005, 12090903, 12131005, 12290912, 12291012, 90091106, LNR; f. Model Number CM-7131, Lot Codes: 1130907, 2111207, 3151121, 3291016, 4211102, 5181011, 6211016, 7010911, 7081017, 7231008, 7281009, 7311216, 8041107, 8060805, 8161101, 8221103, 8311136, 8311137, 8311138, 8311139, 9081009, 9091107, 9170906, 9220908, 10211010, 11090904, 11161015, 11171015, 12171118, 12290911, 12291013, LNR;
- Product
- AperFix Femoral Implant Coring Removal Drill, labeled as the following: a. Femoral Removal Coring Reamer 9mm, Model Number CM-7109; b. Femoral Removal…
- Recalling firm
- Cayenne Medical Inc.
- Quantity
- 1,444 units total
- Distribution
- Worldwide distribution. US nationwide, Denmark, Finland, Malaysia, Netherlands, Poland, Switzerland, and Turkey.
- Recall date
- August 1, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)