Reported Dec 30, 2015 · Terminated
Label reading in part as: "NexGen System, Complete Knee Solution; Reference Number 5980-37-01; Tibial Component,…
Zimmer Manufacturing B.V.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Zimmer Manufacturing B.V. · Turpeaux Industrial Park Rd 1 km 123.4 · Mercedita, PR · 00715
Is this the product you have?
- Label reading in part as"NexGen System, Complete Knee Solution; Reference Number 5980-37-01; Tibial Component, Precoat, Stemmed Size 3
- Lot Number62460264. 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
- Lot codes and dates
- lot #62460264
- Amount recalled
- 179
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
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Zimmer Manufacturing B.V. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.