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

Label reading in part as: "NexGen System, Complete Knee Solution… — recall Z-0449-2016

U.S. FDA — Device Enforcement · United States · 2015-12-02 · Class II

As described by U.S. FDA — Device Enforcement: Label reading in part as: "NexGen System, Complete Knee Solution; Reference Number 5980-37-01; Tibial Component, Precoat, Stemmed Size 3; Lot Number:62460264. Indicated for patients with severe knee pain and disability and is intended for mating with a UHMWPE articular surface and Zimaloy Cobal

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked on this page. No AI-generated text appears on this page. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0449-2016
Date of alert
2015-12-02
Country / jurisdiction
United States
Risk level
Class II
Notice type
recall
Brand
Zimmer Manufacturing B.V.
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
US Distribution and the country of Thailand.
Reported risk: Complaints were received from Thailand reporting that there was no white paper (Tyvek) seal on the inner package of P/N:00-5980-037-01 unit from lot #62460264
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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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