Biomet Offset Tibial Tray 2.5 mm Adaptor, REF 141490 Sterile, QTY.1 Product Usage: Knee joint replacement prostheses intended for ap...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0533-2013.
Biomet investigation identified that the square end of the offset tibial tray adaptor locking insert is oversized and may not engage insert tool screwdriver. This could cause a possible delay in surgery greater than 30 minutes, potentially exposing the patient to the increased risks from being under anesthesia for a longer duration.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0533-2013.
Recall terminated by FDA.
✅ What you should do
- Stop using the product if you own it.
- Check the model number, lot code, or sell-by date against the recall notice above.
- Contact Biomet, Inc. or the retailer where you bought it for a refund, replacement, or repair.
- For the most current official instructions, visit the FDA recall page.
- If you've been hurt by this product, report the incident to FDA.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0533-2013.
Biomet, Inc.
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Biomet, Inc. Recall FAQ
Biomet, Inc. is the subject of a medical implants safety report: Biomet Offset Tibial Tray 2.5 mm Adaptor, REF 141490 Sterile, QTY.1 Product Usage: Knee joint replacement prostheses intended for ap.... The notice was published on November 15, 2012 by the U.S. Food and Drug Administration (FDA). Approximately 200 units are potentially affected.