Device recall
Z-2070-2023: SurgiMend PRS; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes…
FDA device recall · Class II · TEI Biosciences, Inc.
Key facts
| Recall number (Z-number) | Z-2070-2023 |
|---|---|
| Recall event | 92481 |
| Product | SurgiMend PRS; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x15 cm Semi-Oval, 7x17 cm Fenestrated, 10x20 cm Fenestrated, 8x16 cm Semi-Oval, 15x15 cm Semi-Oval, 8x20 cm Fenestrated, 10x15 cm Slant Fenestrated, 7x17 cm Semi-Oval, 8x16 cm Thin Semi-Oval, 10x20 cm Thin Semi-Oval… |
| Product code | FTM |
| Recalling firm | TEI Biosciences, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K071807, K171357 |
| 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