Recall Z-1338-2019— Integra Limited
Class II · Terminated
Class II FDA medical device recall by Integra Limited, initiated 2019-03-31, terminated 2020-05-07. It names one FDA 510(k) clearance: K072113. 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.
- Recalling firm
- Integra Limited
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-03-31
- Terminated
- 2020-05-07
- Firm location
- Plainsboro, NJ, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.