Class II — Biomet Microfixation, LLC
| Recalling firm | BIOMET MICROFIXATION |
|---|---|
| Registered facility | BIOMET MICROFIXATION (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Product mix occurred prior to final package and labeling process. |
| 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. |
| Quantity | 1 |
| Distribution | Worldwide Distribution to Denmark only. |
| Initiated | 2013-09-20 |
| Classified | 2014-09-02 |
| Terminated | 2014-10-03 |
| Recall number | Z-2566-2014 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Biomet Microfixation, LLC (Z-2566-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/67547/
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