Surgical matrix patches recalled for labeling correction on wound dehiscence management
CorNeat EverPatch permanent tissue-integrating surgical matrices are the subject of a retroactive labeling correction, following complaints, to include prevention and management of wound dehiscence.
What this means for you
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: Rubric level 2 covers precautionary recalls; the action is a labeling correction rather than a defect described in the product.
Plain-English summary
The CorNeat EverPatch, REF 1036295, a permanent tissue-integrating surgical matrix measuring 5.0 mm by 6.5 mm by 100 microns, sterile EO and prescription only, UDI-DI G16010362950, is being recalled. Distribution was nationwide in the United States and internationally.
The action is retroactive and was taken, following complaints, as a labeling correction for permanent tissue-integrating surgical matrices to include prevention and management of wound dehiscence. The FDA classified the action as Class II. The notice does not describe a defect in the product itself.
Surgical centres holding this product should follow the manufacturer's instructions for applying the updated labeling.
The recalled product
- Product
- CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 6.5 mm x 100 um, SterileEO, RX only
- Manufacturer
- CORNEAT VISION, LTD.
- Hazard
- labeling-correction
- surgical-matrix
- class-ii
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)
- UDI-DI: G16010362950
Distribution
Distributed nationwide across the United States.
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