Label reading in part as: "NexGen System — Class II medical device recall Z-0449-2016
Terminated recall by Zimmer Manufacturing B.V., reported 2015-12-30. Complaints were received from Thailand reporting that there was no white paper (Tyvek) seal on the inner packa
| Recall number | Z-0449-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Manufacturing B.V., Mercedita, PR, United States |
| Recall initiated | 2015-12-02 |
| Classified | 2015-12-18 |
| Reported by FDA | 2015-12-30 |
| Terminated | 2016-09-16 |
| Countries outside the US | TH |
| Quantity | 179 |
| Reason classes | packaging |
| Lot numbers | 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.
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0449-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.