Device recall
Z-2078-2023: PriMatrix Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 4x4 cm, 6x6 cm…
FDA device recall · Class II · TEI Biosciences, Inc.
Key facts
| Recall number (Z-number) | Z-2078-2023 |
|---|---|
| Recall event | 92481 |
| Product | PriMatrix Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 4x4 cm, 6x6 cm, 8x8 cm, 14mm Disc, 18mm Disc, 2x2 cm, and 10x25 cm (Meshed 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