CorNeat EverPatch surgical patches (REF: 1036295) require labeling update to prevent tissue dehiscence. Affected patients should contact manufacturer for guidance.
Retroactive; Due to complaints, labeling correction for permanent tissue-integrating surgical matrices to include prevention and management of would dehiscence.
CorNeat EverPatch surgical patches (REF: 1036295) were recalled due to labeling corrections needed to prevent tissue dehiscence. This recall addresses a labeling issue that could affect proper wound care after surgery.
The recall involves labeling corrections for permanent tissue-integrating surgical matrices to prevent tissue dehiscence. This means the patch may not have adequate instructions for managing wound separation after surgery.
Patients who received CorNeat EverPatch surgical patches (REF: 1036295) for medical procedures are affected. Those with surgical wounds requiring this patch type are at most risk.
Check for CorNeat EverPatch surgical patches with REF: 1036295, size 5.0 mm x 6.5 mm x 100 um, and sterile packaging. The UDI-DI code G16010362950 identifies affected units.
Verify the product label for REF: 1036295 and UDI-DI: G16010362950
The recall is for labeling corrections to prevent tissue dehiscence after surgery.
No, but you should check the label for the specific recall code and contact CorNeat for guidance.
Look for REF: 1036295, size 5.0 mm x 6.5 mm x 100 um, and UDI-DI: G16010362950 on the packaging.
We’ve drafted a message you can send CorNeat to request your refund or repair — edit it as you like.
Subject: Recall Z-2537-2025 — CorNeat CorNeat Hello, I own a CorNeat that is covered by recall Z-2537-2025 from CorNeat. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
