Recall Z-1338-2019 ยท KGN Wound Dressing With Animal-Derived Material(S)
Integra Limited
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.
| Date | Mar 31, 2019 |
| Status | Terminated |
| Reason | Stability did not meet acceptance criteria for visual appearance during mixing and force vs. displacement at 6 months |
| Root cause | Under Investigation by 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 custsvcnj@integralife.com. |
| Quantity | 274 units |
| Distribution | Worldwide Distribution - US Nationwide Foreign; Peru, Ecuador, Columbia, Brazil |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072113 | INTEGRA FLOWABLE WOUND MATRIX, MODEL FWD301 Integra Lifesciences Corp., Oct 10, 2007 |