Reported Dec 24, 2014 · Terminated
Ceramic Femoral Head. Intended for use in total hip arthroplasty applications to replace the articular surface of the…
DePuy Orthopaedics, 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: DePuy Orthopaedics, Inc. · 700 Orthopaedic Dr · Warsaw, IN · 46582-3994
Is this the product you have?
- Ceramic Femoral Head. Intended for use in total hip arthroplasty applications to replace the articular surface of the femoral head in primary hip surgery and for the salvage of a failed previous hip surgery.
- Lot codes and dates
- Lot 7928614 CATALOG NO. : 1365-36-740
- Barcode GTIN10603295033684
- Amount recalled
- 19 units worldwide
Where it was sold
Why it was recalled
Two complaints reported that the BIOLOX delta TS Ceramic Femoral Articul/eze12/14 36mm +12 Head (product code 1365-36-740) did not fit like the trial; the definite hip construct felt loose. The loosening refers to tissue tension and not the taper connection between the femoral head and stem. The investigations found that the small size sleeve (+1.5 femoral head offset) was incorrectly used in the
This product could cause temporary or reversible health problems — stop using it.
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