NexGEN System REF 5980-37-01 Tibial Component Size Stemmed 3 Precoat — Class II medical device recall Z-0590-2016
Terminated recall by Zimmer Manufacturing B.V., reported 2016-01-13. A product complaint was received stating that a carton labeled as a Precoat Stemmed Tibia Size 3 was opened fo
| Recall number | Z-0590-2016 |
|---|---|
| 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 | 2015-12-03 |
| Classified | 2016-01-05 |
| Reported by FDA | 2016-01-13 |
| Terminated | 2016-09-15 |
| Countries outside the US | BE, DE, DK, FR, GB, GR, IE, NL, NO, SA, SE, TH |
| Reason classes | labeling |
| Lot numbers | 62491580 |
| Model numbers | 5980-37-01, 5986-37-01 |
Product
NexGEN System REF 5980-37-01 Tibial Component Size Stemmed 3 Precoat, and REF 5986-37-01 Nonaugmentable Tibial Component Option CR/PS/LPS Size Stemmed 3. Tibial component of implanted knee prosthesis.
Reason for recall
A product complaint was received stating that a carton labeled as a Precoat Stemmed Tibia Size 3 was opened for use and the contents were a non-augmented Stemmed Tibia Plate size 3.
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-0590-2016. 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.