Device 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.
Z-0449-2016
Product summary
- Event
- Event 72729
- Status
- Terminated
- Classification
- Class II
- Quantity
- 179
- Official record key
device-enforcement:Z-0449-2016
Official wording
Reason: 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
Code information: lot #62460264
Distribution pattern: US Distribution and the country of Thailand.
Derived failure modes
-
Unknown
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