Zimmer Manufacturing B.V. recalls Label reading in part as: "NexGen System, Complete Knee Solution; Reference Number 5980-37-01; Tibial Component, Precoa…

Recall date

December 2, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0449-2016

FDA classification

Class II

Brand / firm

Zimmer Manufacturing B.V.

Sold / distributed

US Distribution and the country of Thailand.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.