Integra Flowable Wound Matrix Recalled for Stability Failure
Integra Limited is recalling 274 units of Integra Flowable Wound Matrix (Lot 2991332) because the product failed stability testing for visual appearance and force displacement.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a stability failure (visual appearance and force displacement) without reported harm, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Integra Limited is voluntarily recalling 274 units of Integra Flowable Wound Matrix, Catalog No. FWD301, under FDA recall number Z-1338-2019. The device is indicated for the treatment of tunneling and/or undermined wounds, including surgical wounds and diabetic ulcers. The recall is limited to Lot Code 2991332.
The recall was initiated because the product did not meet acceptance criteria for stability. Specifically, the product failed testing for visual appearance during mixing and force versus displacement at 6 months. The agency has classified this recall as Class II.
The affected units were distributed worldwide, including the United States, Peru, Ecuador, Colombia, and Brazil. Healthcare providers and patients should stop using the affected product and contact their supplier or Integra Limited for further instructions.
The recalled product
- 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…
- Manufacturer
- Integra Limited
- Category
- Medical Device — Wound Care
- Affected units
- 274
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Code: 2991332
Distribution
Distributed nationwide across the United States.
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