Reported Jul 11, 2018 · Terminated
LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-336
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?
- LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-336
- Lot codes and dates
4 of 4 products
Products covered by this recall Model / number Product as published 9MKA— — PNAMKA AMKAX1— — PNDMKA R56MLE R5JMLE R5KMLE R6MMHE R7TMHE R7VMHE R7WMHE TP8MEA TPHMEA TPKMEA TPLMEA TV0MEA TV1MEA TV2MEA TV3MEA TVXMHD TVYMHD TW0MHD TW2MHD TW3MHD V0JMME V6NMEA VLNMEE VN3MEE VN4MEE VP2MHA VPEMHA VPKMHA VVJMMA VVTMMA WAHMHA WAKMHA WLVMJA WMAMJA WMAMJAX1 WMYMJA WXTMMA WXTMMAX1 WXYMMA WXYMMAX1 WXYMMAX2 YHEMHE YHHMHE YHJMHE
This recall covers 8 products
The agency filed one notice per product. You are reading one of them; the other 7 are below.
Where it was sold
- Nationwide
Why it was recalled
The recalling firm has received a higher than expected number of complaints documenting femoral head/hip stem disassociation for certain sizes of femoral heads manufactured prior to March 4, 2011.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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