CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 6.5 mm x 100 um, SterileEO, RX o
FDA device recall Z-2537-2025 · posted 2025-09-05 · Open, Classified
Recall details
- Recalling firm
- CORNEAT VISION, LTD.
- Reason for recall
- Retroactive; Due to complaints, labeling correction for permanent tissue-integrating surgical matrices to include prevention and management of would dehiscence.
- Action taken
- On October 16-17, 2024, Corneat Vision provided customers with an email containing important information concerning the device safety and efficacy related CorNeat EverPatch. Customers were informed that the IFUs were modified to include conditions that may impair healing and reduce he effectiveness of the EverPatch. Surgical practices were advised to maximize success rate.
- Root cause
- Unknown/Undetermined by firm
- Status
- Open, Classified
- Product code
- QWU
- 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 Arg
- Date initiated
- 2024-10-16
- Date posted
- 2025-09-05
- Location
- Ra'Anana, Israel
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CorNeat EverPatch (K223074) | Corneat Vision , Ltd. | 2023-06-02 |