Device recall
Z-1382-2017: OP7543 Design Y Mandible Onlay - Medium - Left and OP7544 Design Y Mandible…
FDA device recall · Class II · Matrix Surgical Holdings, LLC
Key facts
| Recall number (Z-number) | Z-1382-2017 |
|---|---|
| Recall event | 76356 |
| Product | OP7543 Design Y Mandible Onlay - Medium - Left and OP7544 Design Y Mandible Onlay - Medium - Right |
| Product code | KKY |
| Recalling firm | Matrix Surgical Holdings, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 24, 2017 |
| 510(k) numbers | K123908, K133046 |
| FEI number | 3009383407 |
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