Class II — Integra Limited
| Recalling firm | Integra LifeSciences Corporation |
|---|---|
| Registered facility | View this company's 15 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Stability did not meet acceptance criteria for visual appearance during mixing and force vs. displacement at 6 months |
| 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. |
| Quantity | 274 units |
| Distribution | Worldwide Distribution - US Nationwide Foreign; Peru, Ecuador, Columbia, Brazil |
| Initiated | 2019-03-31 |
| Classified | 2019-05-15 |
| Terminated | 2020-05-07 |
| Recall number | Z-1338-2019 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Integra Limited (Z-1338-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/82653/
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