FDA Device recall Z-0509-2015
Total Temporomandibular Joint Replacement System- 45mm Lft Narrow Ti Mand
- 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- 45mm Lft Narrow Ti Mand 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-0509-2015 |
| 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- 45mm Lft Narrow Ti Mand
Reason
Laser etching on the parts is wider and deeper than the conditions previously validated.
Identifiers
| code_info | Model 01-6546TI, Lot #s: 531880B, 535890B, 531870A, 531870B, 531880A, 535890D, 535890A, 535890C. |
|---|
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-0509-2015%22
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