Integra Meshed Dermal Regeneration Template Recalled for Calculation Error
Integra LifeSciences is recalling 14 packages of Meshed Dermal Regeneration Template due to an incorrect calculation of peel strength test results.
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 identifies the cause as a calculation error in historical test results rather than a confirmed defect or reported injury, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Integra LifeSciences Corporation is recalling 14 packages of Meshed Dermal Regeneration Template, 5 cm x 5 cm (Catalogue No. MIDRT 8101, Lot No. 105A00324750). The product is a bilayer membrane system used for skin replacement in the treatment of thermal injuries and scar contractures.
The recall was initiated after Integra's post-QA release review identified that the average result for the Peel Strength test was incorrectly calculated for this specific lot. The agency has classified this recall as Class II.
The affected product was distributed nationwide to Pennsylvania. Consumers and healthcare providers should stop using the recalled product and contact Integra LifeSciences Corporation for further instructions.
The recalled product
- Product
- Integra Meshed Dermal Regeneration Template 5 cmx 5 cm (2 in x 2in) Rx Only Meshed Integra¿ Dermal Regeneration Template, (Integra template) is a bilayer membrane system for skin replacement. The dermal replacement layer is made of a porous matrix of fibers of cross-linked…
- Manufacturer
- Integra LifeSciences Corporation
- Hazard
- Affected units
- 14
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)
- Catalogue No. MIDRT 8101 Lot No. 105A00324750
Distribution
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