FDAFDA · Food and drugs·Recall number Z-0825-2015
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.
Published December 24, 2014 · Recall initiated: November 7, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- DePuy Orthopaedics, Inc.
- Distributor
- Distributed in the states of WV, AZ, and AL, and the countries of Germany, and Finland.
- Lot
- Lot 7928614 CATALOG NO. : 1365-36-740 Barcode GTIN: 10603295033684
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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