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 | Potential sterility deficiency. |
| Product | Hard Tissue Replacement (HTR) Implant, Rx only, for use in single procedure only. Custom made. HTR polymer implants are intended for bone replacement/augmentation for treatment of craniofacial voids/defects resulting from disease, injury, or surgical trauma. |
| Quantity | 54 units |
| Distribution | Worldwide Distribution - US including AZ, CA, FL, MO, NH, PA, TX, & VA, and Internationally to Austria, Canada, England, Germany, Greece, Italy, Netherlands, & South Africa. |
| Initiated | 2016-06-13 |
| Classified | 2016-09-08 |
| Terminated | 2019-08-21 |
| Recall number | Z-2751-2016 |
| 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-2751-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/74798/
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