FDA Device recall Z-1338-2019
Integra Flowable Wound Matrix Catalog No: FWD301 Product Usage: Integra Flowable Wound Matrix is indicated for the treatment of tunneling a…
- FDA Device
- Class II
- terminated
- Published 2019-05-22
On 2019-05-22 the FDA classified a Class II recall of Integra Flowable Wound Matrix Catalog No: FWD301 Product Usage: Integra Flowable Wound Matrix is indicated for the treatment of tunneling a… by Integra, citing stability did not meet acceptance criteria for visual appearance during mixing and force vs. displacement at 6 months.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1338-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-03-31 |
| Published | 2019-05-22 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Integra |
| Distribution | US |
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 of both partial and full-thickness varieties. The device is intended for one-time use.
Reason
Stability did not meet acceptance criteria for visual appearance during mixing and force vs. displacement at 6 months
Identifiers
| code_info | Lot Code: 2991332 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1338-2019%22
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