Reported Nov 16, 2016 · Terminated
LFIT Anatomic V40 Femoral Head, Low Friction Ion Treatment, Sterile, 36 mm, REF 6260-9-236; Modular components designed…
Stryker 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: Stryker Howmedica Osteonics Corp. · 325 Corporate Dr · Mahwah, NJ · 07430-2006
Is this the product you have?
- LFIT Anatomic V40 Femoral Head, Low Friction Ion Treatment, Sterile, 36 mm, REF 6260-9-236; Modular components designed to be locked onto a femoral hip stem trunnion during surgery for total hip replacement.
- Lot codes and dates
6 of 6 products
Products covered by this recall Model / number Product as published 6260-9-236Head Diameter 36 mm, Offset +5, including all lots manufactured from 1/102 - 7/1/10 6260-9-240Head Diameter 40 mm, Offset +4, including all lots manufactured from 1/1/06 - 3/4/11 6260-9-244Head Diameter 44 mm, Offset +4, including all lots manufactured from 1/1/06 - 3/4/11 6260-9-340Head Diameter 40 mm, Offset +8, including all lots manufactured from 1/1/06 - 3/4/11 6260-9-440Head Diameter 40 mm, Offset +12, including all lots manufactured from 1/1/06 - 3/4/11 6260-9-444Catalog #6260-9-344 - Head Diameter 44 mm, Offset +8, including all lots manufactured from 1/1/07 - 3/4/11 and - Head Diameter 44 mm, Offset +12, including all lots manufactured from 1/1/06 - 3/4/11. - Amount recalled
- 42,519 units (total Catalog numbers)
Where it was sold
- Nationwide
Why it was recalled
Stryker received several complaints describing incidence of harm secondary to taper lock failure for specific lots of numerous catalog numbers of LFIT Anatomic CoCr V40 Femoral Heads.
This product could cause temporary or reversible health problems — stop using it.
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