Recall record at a glance
| Official record | Z-1338-2019 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Integra Limited |
| Report date | May 22, 2019 |
| Recall initiation date | Mar 31, 2019 |
| Quantity | 274 units |
| Location | Plainsboro, NJ, United States |
Official 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.
Why the product was recalled
Stability did not meet acceptance criteria for visual appearance during mixing and force vs. displacement at 6 months
Distribution information
Worldwide Distribution - US Nationwide Foreign; Peru, Ecuador, Columbia, Brazil
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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