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

Recall Z-2289-2018 — Vanguard Complete Knee System; E1 Vanguard PS Tibial Bearing; Model Numbers EP-183664, EP-183642 Product Usage: The product is intended for use in knee joint replacement arthroplasties.

U.S. FDA — Device Enforcement · United States · 2018-05-24 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2289-2018
Date of alert: 2018-05-24
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Zimmer Biomet, Inc.
Product category: device
Product type: Devices

Reported risk: Two lots of tibial bearings were commingled. There is a possibility that a 14mm tibial bearing is packaged in a box labeled as 12 mm tibial bearing and vice versa. This may lead to extension of surgery to find another implant.

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.

Recall Z-2289-2018 — Vanguard Complete Knee System; E1 Vanguard PS Tibial Bearing; Model Numbers EP-183664, EP-183642 Product Usage: The product is intended for use in knee joint replacement arthroplasties.

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