Total Temporomandibular Joint Replacement System- 50mm Rt Stand Off… — Class II medical device recall Z-0516-2015
Terminated recall by Biomet Microfixation, LLC, reported 2014-12-17, distributed in CA, MN, PA. Laser etching on the parts is wider and deeper than the conditions previously validated.
| Recall number | Z-0516-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biomet Microfixation, LLC, Jacksonville, FL, United States |
| Recall initiated | 2014-10-17 |
| Classified | 2014-12-08 |
| Reported by FDA | 2014-12-17 |
| Terminated | 2017-01-04 |
| Distributed | CA, MN, PA |
| Countries outside the US | AU, FR, GB, NL |
| Quantity | 42 |
| Lot numbers | 531960A, 531960B |
| Model numbers | 24-6650TI |
Product
Total Temporomandibular Joint Replacement System- 50mm Rt Stand Off Ti Mand Reconstruction of the temporomandibular joint
Reason for recall
Laser etching on the parts is wider and deeper than the conditions previously validated.
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-0516-2015. 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.