Ceramic Femoral Head. Intended for use in total hip arthroplasty applications to replace the articular surface of the femoral head i...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0825-2015.
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
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0825-2015.
Recall terminated by FDA.
🩺 Talk to your doctor or pharmacist
Product Recall Tracker does not provide medical advice. Any specific instructions about this medication or device come directly from the FDA notice above. Before making any change to your treatment:
- Do not stop, change, or discard your prescription on your own.
- Call your doctor or pharmacist and ask whether this FDA notice applies to your prescription (have the brand name, dosage, and lot number ready if you can find them).
- Follow your clinician's guidance on whether to continue, switch, or return the product.
- If you have experienced a reaction, seek medical care and report it to the FDA via MedWatch.
- For the official FDA notice, visit the FDA recalls page.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0825-2015.
DePuy Orthopaedics, Inc.
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If you had an adverse reaction, side effect, or device malfunction from this medication or device, report it to the FDA through MedWatch. Talk to your doctor or pharmacist first — do not stop a prescription on your own. Reports help the FDA detect rare or emerging safety signals and can lead to label changes or recalls.
Depuy Orthopaedics, Inc. Recall FAQ
Depuy Orthopaedics, Inc. is the subject of a medical devices safety report: Ceramic Femoral Head. Intended for use in total hip arthroplasty applications to replace the articular surface of the femoral head i.... The notice was published on November 7, 2014 by the U.S. Food and Drug Administration (FDA). Approximately 19 units are potentially affected.