Hard Tissue Replacement — Class II medical device recall Z-2751-2016
Terminated recall by Biomet Microfixation, LLC, reported 2016-09-14, distributed in AZ, CA, FL, MO, NH, PA, TX, VA. Potential sterility deficiency.
| Recall number | Z-2751-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biomet Microfixation, LLC, Jacksonville, FL, United States |
| Recall initiated | 2016-06-13 |
| Classified | 2016-09-08 |
| Reported by FDA | 2016-09-14 |
| Terminated | 2019-08-21 |
| Distributed | AZ, CA, FL, MO, NH, PA, TX, VA |
| Countries outside the US | AT, CA, DE, GB, GR, IT, NL, ZA |
| Quantity | 54 units |
| Reason classes | sterility |
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.
Reason for recall
Potential sterility deficiency.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2751-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.