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

Recall Z-2373-2012 — Omnilife Science Apex Knee System Modular Tibia Augment, Size 4 x 4mm Ref: KC-54040. The Apex Knee System is intended for use as a primary or revision total knee replacement.

U.S. FDA — Device Enforcement · United States · 2012-08-09 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2373-2012
Date of alert
2012-08-09
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Omni Life Science
Product category
device
Product type
Devices
Reported risk: The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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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.