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.
FDA Recall Z-1338-2019 · Posted None
Recalling FirmIntegra Limited
Recall StatusTerminated
Product CodeKGN
Date Initiated2019-03-31
Date Terminated2020-05-07
Product Quantity274 units
Reason for Recall
Stability did not meet acceptance criteria for visual appearance during mixing and force vs. displacement at 6 months
Firm Action
Integra Lifesciences notified consignees (Hospitals, Distributors and Sales reps) by letter delivered by courier service, facsimile or email on April 1st, 2019. Letter identifies problems, health risk and action to take: review inventory, immediately stop use and return product and complete the Acknowledgment form.
Questions Contact Customer Service at 1-800-654-2873 Monday to Friday 8:00 AM 8:00 PM EST or [email protected].
Root Cause
Under Investigation by firm
Distribution Pattern
Worldwide Distribution - US Nationwide Foreign; Peru, Ecuador, Columbia, Brazil
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.