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

Recall Z-1938-2014 — NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 7. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.

U.S. FDA — Device Enforcement · United States · 2014-05-19 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1938-2014
Date of alert: 2014-05-19
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Zimmer, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 37214653

Reported risk: Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification.

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-1938-2014 — NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 7. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.

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