FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-1338-2019
- Recalling firm
- Integra Limited
- 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.
- Status
- Terminated
- Initiated
- 2019-03-31
- Posted
- not on file
- Terminated
- 2020-05-07
- 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
- Lot, serial or model codes
- Lot Code: 2991332
- 510(k) numbers
- ["K072113"]
- PMA numbers
- not on file
- Product code
- KGN
- Firm FEI
- 3001700044
- Firm city
- Plainsboro
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28