Reported May 22, 2019 · Terminated
Integra Flowable Wound Matrix Catalog No: FWD301 Product Usage: Integra Flowable Wound Matrix is indicated for the…
Integra Limited
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Integra Limited · 311 Enterprise Dr · Plainsboro, NJ · 08536-3344
Is this the product you have?
- Integra
- Flowable Wound Matrix Catalog NoFWD301
- Product UsageIntegra Flowable Wound Matrix is indicated for the treatment of tunneling
- and/or undermined wounds includingsurgical 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
- Lot codes and dates
- Lot Code2991332
- Amount recalled
- 274 units
Where it was sold
- Nationwide
Why it was recalled
Stability did not meet acceptance criteria for visual appearance during mixing and force vs. displacement at 6 months
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Integra Limited recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.