FDA Device recall Z-2566-2014
Biomet Microfixation Temporomandibular Joint (TMJ) Patient Matched Left Fossa Part# CP751506 The Total Temporomandibular Joint (TMJ) replac…
- FDA Device
- Class II
- terminated
- Published 2014-09-10
On 2014-09-10 the FDA classified a Class II recall of Biomet Microfixation Temporomandibular Joint (TMJ) Patient Matched Left Fossa Part# CP751506 The Total Temporomandibular Joint (TMJ) replac… by Biomet Microfixation, citing product mix occurred prior to final package and labeling process.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2566-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-09-20 |
| Published | 2014-09-10 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Biomet Microfixation |
| Distribution | n/a |
Product
Biomet Microfixation Temporomandibular Joint (TMJ) Patient Matched Left Fossa Part# CP751506 The Total Temporomandibular Joint (TMJ) replacement system is implanted in the jaw to functionally reconstruct a diseased and/or damaged temporomandibular joint. The Total TMJ replacement system is a two-component system comprised of mandibular condyle and a glenoid fossa components. Both components are available in multiple stock sizes as right and left specific designs and are attached to the bones by screws.
Reason
Product mix occurred prior to final package and labeling process.
Identifiers
| code_info | Part #CP751506 Lot #478490 |
|---|
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-2566-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.