Z-1338-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 22, 2019
- Initiation Date
- March 31, 2019
- Termination Date
- May 7, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 274 units
Product Description
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
Distribution Pattern
Worldwide Distribution - US Nationwide Foreign; Peru, Ecuador, Columbia, Brazil
Code Information
Lot Code: 2991332