Device 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.
Z-1338-2019
Product summary
- Firm
- Integra Limited
- Event
- Event 82653
- Status
- Terminated
- Classification
- Class II
- Quantity
- 274 units
- Official record key
device-enforcement:Z-1338-2019
Official wording
Reason: Stability did not meet acceptance criteria for visual appearance during mixing and force vs. displacement at 6 months
Code information: Lot Code: 2991332
Distribution pattern: Worldwide Distribution - US Nationwide Foreign; Peru, Ecuador, Columbia, Brazil
Derived failure modes
-
Unknown
Stability did not meet acceptance criteria for visual appearance during mixing and force vs. displacement at 6 months