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 | Laser etching on the parts is wider and deeper than the conditions previously validated. |
| Product | Total Temporomandibular Joint Replacement System- 45mm Lft Stand Off Ti Mand Reconstruction of the temporomandibular joint |
| Quantity | 42 |
| Distribution | Worldwide Distribution - USA including PA, MN, CA and Internationally to Australia, Netherlands, France, and United Kingdom. |
| Initiated | 2014-10-17 |
| Classified | 2014-12-08 |
| Terminated | 2017-01-04 |
| Recall number | Z-0510-2015 |
| 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-0510-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/69644/
Alerts for BIOMET MICROFIXATION
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.