Device product
CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 6.5 mm x 100 um, SterileEO, RX only
Z-2537-2025
Product summary
- Event
- Event 97281
- Status
- Ongoing
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-2537-2025
Official wording
Reason: Retroactive; Due to complaints, labeling correction for permanent tissue-integrating surgical matrices to include prevention and management of would dehiscence.
Code information: UDI-DI: G16010362950
Distribution pattern: 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.
Derived failure modes
-
Unknown
Retroactive; Due to complaints, labeling correction for permanent tissue-integrating surgical matrices to include prevention and management of would dehiscence.