Reported Oct 9, 2019 · Terminated
TRIATHLON FEMORAL DISTAL AUGMENT 10MM - SIZE 2 LEFT Catalog # 5541-A-201 - Product Usage: Triathlon Femoral Distal…
Howmedica Osteonics Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Howmedica Osteonics Corp. · 325 Corporate Dr · Mahwah, NJ · 07430-2006
Is this the product you have?
- TRIATHLON FEMORAL DISTAL AUGMENT 10MM - SIZE 2 LEFT Catalog # 5541-A-201 -
- Product UsageTriathlon Femoral Distal Augments are used with Triathlon TS Femoral Components during revision Total Knee Arthroplasty (TKA) and with Triathlon Primary PS Femoral Components during TKA to address distal femoral defects. (See attached IFU (IFU_Triathlon Total Knee_QIN 4376 Rev AB)
- Lot codes and dates
- All lots with an expiration date on or before 31 June 2024. Lot # A3A4G A3O4G A7E4A A7S7Y AABP AABRDNVL 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
AAS7LABI3LABY7AAE44HAEB7HAER7YAGS7HAHS4DAIA7YAII4ZALR4LAOU3RARG9TASZ3OATG4XATU7DAVG7ZAVO9HAYG9YAYX3YBAE3EBAU3LBE93TBEB4LBGU4GBHL9OBIE7HBL74IBLL9ABRE9EBRO7UBRY4YBS97EBSH7HBSO3GBTE4D
- All lots with an expiration date on or before 31 June 2024. Lot # A3A4G A3O4G A7E4A A7S7Y AABP AABR
- Amount recalled
- 167 units
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
Due to device overhang issue that protrudes beyond the medial periphery of the mating femoral component
This product could cause temporary or reversible health problems — stop using it.
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