Device recall
Z-0911-2020: GIBSON Healthcare Membrane Extended, 20mm x 30mm, Reference Number 5303-324…
FDA device recall · Class II · Collagen Matrix Inc
Key facts
| Recall number (Z-number) | Z-0911-2020 |
|---|---|
| Recall event | 84334 |
| Product | GIBSON Healthcare Membrane Extended, 20mm x 30mm, Reference Number 5303-324 - Product Usage: Indicated for use in oral surgical procedures as a resorbable material for use in augmentation around implants placed in immediate extraction sockets, delayed extraction sockets; localized ridge augmentation… |
| Product code | NPL |
| Recalling firm | Collagen Matrix Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 3, 2020 |
| 510(k) numbers | K100156 |
| FEI number | 3008817245 |
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