FDA recall Z-0039-2026

Product

CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 605 mm x 100 ¿m

Reason for recall

Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch.

Distribution

Worldwide - US Nationwide distribution in the states of AZ, CA, CO, CT, DC, DE, FL, GA, ID, IL, IN, KS, MA, MD, MI, MN, MO, MT, NC, NY, OH, PA, SC, TN, TX, UT, VA, WA, WI and the countries of Japan, Israel, Argentina, Hong Kong.

Key facts

Status

Ongoing

Initiation date

2025-08-18

Report date

2025-10-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Ra'Anana, Israel

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0039-2026