FDA Device recall Z-0517-2015
Total Temporomandibular Joint Replacement System- 50mm Rt Standard Ti Mand Reconstruction of the temporomandibular joint
- FDA Device
- Class II
- terminated
- Published 2014-12-17
On 2014-12-17 the FDA classified a Class II recall of Total Temporomandibular Joint Replacement System- 50mm Rt Standard Ti Mand Reconstruction of the temporomandibular joint by Biomet Microfixation, citing laser etching on the parts is wider and deeper than the conditions previously validated.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0517-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-10-17 |
| Published | 2014-12-17 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Biomet Microfixation |
| Distribution | CA, MN, PA |
Product
Total Temporomandibular Joint Replacement System- 50mm Rt Standard Ti Mand Reconstruction of the temporomandibular joint
Reason
Laser etching on the parts is wider and deeper than the conditions previously validated.
Identifiers
| code_info | Model 24-6650TI, Lot #s: 518480B, 518480A, 525970A, 525970B, 525980B, 518490A, 526070A, 525990A, 525990B, 526060A, 5260…Model 24-6650TI, Lot #s: 518480B, 518480A, 525970A, 525970B, 525980B, 518490A, 526070A, 525990A, 525990B, 526060A, 526060B, 526070B, 525980A, 550330A, 550330B, 550340A, 550340B, 550350A, 550360A, 550360B, 518490B, 525960A, 525960B, |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0517-2015%22
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