Device recall
Z-2079-2023: PriMatrix Meshed; Dermal Repair Scaffold; Rx Only; Sizes 20x25 cm (1:1), 3x3 cm…
FDA device recall · Class II · TEI Biosciences, Inc.
Key facts
| Recall number (Z-number) | Z-2079-2023 |
|---|---|
| Recall event | 92481 |
| Product | PriMatrix Meshed; Dermal Repair Scaffold; Rx Only; Sizes 20x25 cm (1:1), 3x3 cm (2:1), 4x4 cm (2:1), 5x5 cm (2:1), 6x6 cm (2:1), 8x12 cm (2:1), and 8x8 cm (2:1). |
| Product code | KGN |
| Recalling firm | TEI Biosciences, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K153690 |
| FEI number | 3004170064 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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