Device recall
Z-1338-2019: Integra Flowable Wound Matrix Catalog No: FWD301 Product Usage: Integra Flowable…
FDA device recall · Class II · Integra Limited
Key facts
| Recall number (Z-number) | Z-1338-2019 |
|---|---|
| Recall event | 82653 |
| Product | Integra Flowable Wound Matrix Catalog No: FWD301 Product Usage: Integra Flowable Wound Matrix is indicated for the treatment of tunneling and/or undermined wounds including: surgical wounds (donor sites/grafts, post-Moh s surgery, post-laser surgery, podiatric, wound dehiscence) and diabetic ulcers… |
| Product code | KGN |
| Recalling firm | Integra Limited |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 7, 2020 |
| 510(k) numbers | K072113 |
| FEI number | 3001700044 |
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