Device recall
Z-2073-2023: SurgiMend MP; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes…
FDA device recall · Class II · TEI Biosciences, Inc.
Key facts
| Recall number (Z-number) | Z-2073-2023 |
|---|---|
| Recall event | 92481 |
| Product | SurgiMend MP; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x15 cm, 20x20 cm, 13x25 cm, 16x20 cm, 20x25 cm, 20x30 cm, and 25x40 cm. |
| Product code | FTM |
| Recalling firm | TEI Biosciences, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K162965 |
| 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