FDAHealthOctober 16, 2024
CORNEAT VISION, LTD. — CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 6.5 mm x 100 um, SterileEO, RX only
⚠️ Retroactive; Due to complaints, labeling correction for permanent tissue-integrating surgical matrices to include prevention and management of would dehiscence.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- October 16, 2024
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.
What's affected?
- Product
- CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 6.5 mm x 100 um, SterileEO, RX only
- Brand
- CORNEAT VISION, LTD.
- Lot code
- UDI-DI: G16010362950
Additional details
UDI-DI: G16010362950
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: N/A.
Get Health recall alerts
Delivered to your inbox. Free. No account required.