Reported Apr 5, 2023 · Ongoing
CoCr Femoral Head, XS, 38/-8, Taper 12/14-Intended to be used as a modular head component for articulation in total hip…
Zimmer, Inc.
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: Zimmer, Inc. · 1800 W Center St · Warsaw, IN · 46580-2304
Is this the product you have?
- CoCr Femoral Head, XS, 38/-8, Taper 12/14-Intended to be used as a modular head component for articulation in total hip arthroplasty
- Item Number01.01012.384
- Lot codes and dates
- GTIN Number00889024283268 All lots
- Amount recalled
- 1,168 untits
Where it was sold
Why it was recalled
Update the compatibility matrix as referred to in the Instructions for Use (IFU) for the CoCr Femoral Head XS- removes the compatibility with the Epsilon Durasul Constrained Acetabular Liners from the matrix due to the range of motion in flexion/extension being less than 100 degrees as recommended per an internationally recognized standard (ISO 21535:2009
This product could cause temporary or reversible health problems — stop using it.
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