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Zimmer Manufacturing B.V. recalls Label reading in part as: "NexGen System, Complete Knee Solution; Reference Number 5980-37-01; Tibial Component, Precoat
Recalled December 30, 2015 · FDA recall Z-0449-2016 · Zimmer Manufacturing B.V
Hazard
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 · FDA Class II
Units
179
Sold at
US Distribution and the country of Thailand.
Description
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
Product
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 Cobalt-Chromium-Molybdenum alloy femoral component to perform knee arthroplasty.
Manufacturer(s)
Zimmer Manufacturing B.V.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →