Biomet Integral Centralizer Hip System — Class II medical device recall Z-0650-2016
Terminated recall by Biomet, Inc., reported 2016-01-20, distributed nationwide. PMMA is listed as a material on the label but the product does not contain PMMA.
| Recall number | Z-0650-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2015-11-17 |
| Classified | 2016-01-13 |
| Reported by FDA | 2016-01-20 |
| Terminated | 2016-07-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, NL |
| Quantity | 21 |
| Reason classes | labeling |
| Lot numbers | 311410, 329750, 329760, 404380, 410500, 487400, 505030, 505050, 535530, 712800, 728080, 767120, 829580, 837750, 951680, 977460 |
| Model numbers | 11-162709, 11-162711, 11-162713, 11-162715, 11-162717, 11MM, 13MM, 15MM, 17MM, 311410, 329750, 329760, 404380, 410500, 487400, 505030, 505050, 535530, 712800, 728080, 767120, 772410, 829580, 837750, 837780 and 5 more |
Product
Biomet Integral Centralizer Hip System, Lateralized Femoral Stem (Co-Cr-Mo), 9mm, 11mm, 13mm, 15mm, and 17mm
Reason for recall
PMMA is listed as a material on the label but the product does not contain PMMA.
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-0650-2016. 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.