Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0533-2013 — Biomet Offset Tibial Tray 2.5 mm Adaptor, REF 141490 Sterile, QTY.1 Product Usage: Knee joint replacement prostheses intended for application with or without bone cement. Knee joint replacement components include femoral, tibial, and patellar components, intended for both primary and revision a

U.S. FDA — Device Enforcement · United States · 2012-11-15 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0533-2013
Date of alert: 2012-11-15
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Biomet, Inc.
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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