Recall Z-2537-2025— CORNEAT VISION, LTD.
Class II · Ongoing
Class II FDA medical device recall by CORNEAT VISION, LTD., initiated 2024-10-16. It names one FDA 510(k) clearance: K223074. Product: CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 6.5 mm x 100 um, SterileEO, RX only. Reason: Retroactive; Due to complaints, labeling correction for permanent tissue-integrating surgical matrices to include prevention and management of would dehiscence..
- Recalling firm
- CORNEAT VISION, LTD.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-10-16
- Firm location
- Ra'Anana, N/A, Israel
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 6.5 mm x 100 um, SterileEO, RX only
Reason for recall
Retroactive; Due to complaints, labeling correction for permanent tissue-integrating surgical matrices to include prevention and management of would dehiscence.
Data sourced from openFDA. This site is unofficial and independent of the FDA.