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

Recall Z-1607-2024 — Vanguard Knee System AS Tibial Bearing / DCM ArCom, 12 MM X 75 MM; Model Number 189082. The product is placed into a foil pouch with protective packaging in the form of a polyurethane bag, and sealed closed (inner barrier). The inner barrier is then placed into a PETG tray and sealed with Tyvek li

U.S. FDA — Device Enforcement · United States · 2024-03-13 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1607-2024
Date of alert: 2024-03-13
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Biomet, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 65966530

Reported risk: Possible damage to the Vanguard Knee System AS Tibial Bearing caused during the manufacturing process.

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.

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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