Integra Flowable Wound Matrix Catalog No: FWD301 Product Usage:… — Class II medical device recall Z-1338-2019
Terminated recall by Integra Limited, reported 2019-05-22, distributed nationwide. Stability did not meet acceptance criteria for visual appearance during mixing and force vs. displacement at 6
| Recall number | Z-1338-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Integra Limited, Plainsboro, NJ, United States |
| Recall initiated | 2019-03-31 |
| Classified | 2019-05-15 |
| Reported by FDA | 2019-05-22 |
| Terminated | 2020-05-07 |
| Distributed | Nationwide (US) |
| Countries outside the US | BR, EC, PE |
| Quantity | 274 units |
| Reason classes | specification failure |
| Lot numbers | 2991332 |
| Model numbers | FWD301 |
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 for recall
Stability did not meet acceptance criteria for visual appearance during mixing and force vs. displacement at 6 months
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1338-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.