Triathlon Femoral Distal Augment 10mm recall
TRIATHLON FEMORAL DISTAL AUGMENT 10MM - SIZE 2 LEFT Catalog # 5541-A-201 - Product Usage: Triathlon Femoral Distal Augments are used with Triathlon TS…
Why was Triathlon Femoral Distal Augment 10mm recalled?
Due to device overhang issue that protrudes beyond the medial periphery of the mating femoral component
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?
All lots with an expiration date on or before 31 June 2024. Lot # A3A4G A3O4G A7E4A A7S7Y AABP AABR AAS7L ABI3L ABY7A AE44H AEB7H AER7Y AGS7H AHS4D AIA7Y AII4Z ALR4L AOU3R ARG9T ASZ3O ATG4X ATU7D AVG7Z AVO9H AYG9Y AYX3Y BAE3E BAU3L BE93T BEB4L BGU4G BHL9O BIE7H BL74I BLL9A BRE9E BRO7U BRY4Y BS97E BSH7H BSO3G BTE4D DNVL DRSG DVXW DZKF FUXX FVAH GARO GAWP GBTP GJZD GKAJ GKDW GLAN GLBU GLHI GLHY HHRP HHVI HXGO HXML HXUV HYHY HZBN HZKZ HZNH IBSA IBZA IDZV IKGT IKKM ILHJ INIM INLE ITMY IXNB IYRK JBOV JDJY JEUD JIOX JIYT JJZE JKFX JKYF JLIF JOJF JWEF JWVL JYWU JZYF KEXO KMFK KMGH KMIS KOHJ KPNX KRPW KSNI KUZR KVYS MDZU MLWL MNKY MOHT MPNI MROZ S3HR SSVR TGOB U3BV ULIO USUR UZYY V4ZD VADL VGLG VHWH VJHI VJYL VPSZ VRDA VTYL VWRZ VZVT WDVE WIRA WISA WOTL WOUL WRUR WRUS WVZO WWEP WXTS WXTT WXTU WZP3 XEMZ XENA XHZU XKWY XKWZ XLRY XLRZ XSFN XSFP XSZE XSZF XVJA XVKZ XWVJ XWWZ XYGU XYGV YBJJ YBJK YCZR YCZS YFXP YFXR YGDI YGDZ YHDM YHDN
- Product
- TRIATHLON FEMORAL DISTAL AUGMENT 10MM - SIZE 2 LEFT Catalog # 5541-A-201 - Product Usage: Triathlon Femoral Distal Augments are used with Triathlon TS…
- Recalling firm
- Howmedica Osteonics Corp.
- Quantity
- 167 units
- Distribution
- Worldwide distribution - US Nationwide distribution including the states of 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, WA, WI, WV, WY, and countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Columbia, Denmark, Finland, France, Germany, Honk Kong, India, Ireland, Iran, Italy, Israel, Japan, Kazakhstan, Korea, Kuwait, Malaysia, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Puerto Rico, Romania, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, and UK.
- Recall date
- October 9, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)