various polyethylene implants Knees Revision Tibial Tray Systems… — Class II medical device recall Z-1861-2017
Terminated recall by Zimmer Biomet, Inc., reported 2017-04-26, distributed nationwide. Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.
| Recall number | Z-1861-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2017-02-17 |
| Classified | 2017-04-18 |
| Reported by FDA | 2017-04-26 |
| Terminated | 2018-01-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AU, CA, CH, CL, CN, CR, EC, GB, IN, IT, JP, KR, MX, MY, PA, SG, TH |
| Quantity | 28,253 in |
| Reason classes | sterility |
| Model numbers | 11-150822, 11-150826, 11-150830, 11-150838, 11-150840, 11-150842, 11-150844, 129940, 129950, 129960, 141261, 141262, 141263, 141264, 141265, 141266, 141268, 141481, 141482, 141483, 141484, 141485, 141512, 141514, 141515 and 475 more |
Product
various polyethylene implants Knees Revision Tibial Tray Systems Oxford Partial Knee Orthopedic Salvage System Vanguard Complete Knee System Vanguard SSK Revision System Biomet Patella Maxim Complete Knee System Biomet Series A Patella Vanguard 360 Revision System Vanguard Deep Dish Rotating Platform Biomet CP Bearings Product Usage: For use in total knee arthroplasty. Limb salvage joint reconstruction. Partial knee replacement.
Reason for recall
Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.
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-1861-2017. 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.