Device recall
Z-0679-2022: The DARCO Locking Bone Plate System is designed with rhombus (parallelogram)…
FDA device recall · Class II · Wright Medical Technology, Inc.
Key facts
| Recall number (Z-number) | Z-0679-2022 |
|---|---|
| Recall event | 89461 |
| Product | The DARCO Locking Bone Plate System is designed with rhombus (parallelogram) plates of biocompatible titanium. The plates use either 2.7mm or 3.5mm screws which intersect each other in pairs. The drill holes of the plates are aligned to assure the screws do not touch. The various plates model… |
| Product code | HRS |
| Recalling firm | Wright Medical Technology, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 25, 2024 |
| 510(k) numbers | K061808 |
| FEI number | 3010667733 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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