Device recall
Z-0669-2022: RESODURA matrix onlay 10.0 cm x 12.5 cm - indicated as dural substitutes for the…
FDA device recall · Class II · Collagen Matrix, Inc.
Key facts
| Recall number (Z-number) | Z-0669-2022 |
|---|---|
| Recall event | 89495 |
| Product | RESODURA matrix onlay 10.0 cm x 12.5 cm - indicated as dural substitutes for the repair of dura matter. REF: DUMO10125 |
| Product code | GXQ |
| Recalling firm | Collagen Matrix, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 18, 2024 |
| 510(k) numbers | K061487 |
| FEI number | 3003300673 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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