FDA Device recall Z-2751-2016
Hard Tissue Replacement (HTR) Implant, Rx only, for use in single procedure only
- FDA Device
- Class II
- terminated
- Published 2016-09-14
On 2016-09-14 the FDA classified a Class II recall of Hard Tissue Replacement (HTR) Implant, Rx only, for use in single procedure only by Biomet Microfixation, citing potential sterility deficiency.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2751-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-06-13 |
| Published | 2016-09-14 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Biomet Microfixation |
| Distribution | AZ, CA, FL, MO, NH, PA, TX, VA |
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
Potential sterility deficiency.
Identifiers
| code_info | Custom made, one per customer. Affected units were sealed between April 28, 2016 and June 7, 2016 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2751-2016%22
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