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.
FDA Recall Z-0449-2016 · Posted None
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Recalling FirmZimmer Manufacturing B.V.
Recall StatusTerminated
Product CodeJWH
Date Initiated2015-12-02
Date Terminated2016-09-16
Product Quantity179
Reason for Recall
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
Firm Action
An Urgent Medical Device Recall Letter, dated 12/2/15, was sent to the firm's consignees. All distributors will be notified via electronic mail. Hospital risk managers, surgeons, and distributors with product will be notified via courier.
Root Cause
Packaging
Distribution Pattern
US Distribution and the country of Thailand.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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