CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 6.5 mm x 100 um, SterileEO, RX o
Summary
The FDA issued a Class II for CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5 by CORNEAT VISION, LTD.. Reason: Retroactive; Due to complaints, labeling correction for permanent tissue-integrating surgical matrices to include prevention and management of would d.
Details
Source
Device Recall
External ID
Z-2537-2025
Action Date
2025-09-17
Status
Ongoing
Category
device
Product Description
CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 6.5 mm x 100 um, SterileEO, RX only
Lot/Code Info: UDI-DI: G16010362950
Quantity Affected: N/A
Reason for Recall
Retroactive; Due to complaints, labeling correction for permanent tissue-integrating surgical matrices to include prevention and management of would dehiscence.
Distribution
Worldwide - US Nationwide distribution in the states of AZ, CA, CO, DE, FL, GA, ID, IL, IN, KS, MA, MD, MI, MN, MO, MT, NC, NY, OH, PA, SC, TN, TX, UT, VA, WA, WI, Puerto Rico and the countries of Argentina, Israel, Hong Kong.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-10-16
Company
Ra'Anana, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 168 device recalls issued in the same week, part of 403 device-related FDA actions this month.
CORNEAT VISION, LTD. has 4 FDA actions in our database, including 3 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (CORNEAT VISION, LTD.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does CORNEAT VISION, LTD. have FDA actions?
CORNEAT VISION, LTD. has 4 FDA actions in our database, including 3 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2537-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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