Device recall
Z-2751-2016: Hard Tissue Replacement (HTR) Implant, Rx only, for use in single procedure…
FDA device recall · Class II · Biomet Microfixation, LLC
Key facts
| Recall number (Z-number) | Z-2751-2016 |
|---|---|
| Recall event | 74798 |
| 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. |
| Product code | KKY |
| Recalling firm | Biomet Microfixation, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 21, 2019 |
| 510(k) numbers | K924935 |
| FEI number | 1032347 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database