FDA recall Z-1984-2025

Chamberlain Technologies LLC · Class II · device

Product

SURGIMESH XB, Polymeric Surgical Mesh, 14m x 15cm Flat Sheet with Silicone Barrier, Model/Catalog Number: Tintra R-1415

Reason for recall

Potential presence of residual adhesive material on the mesh surface.

Distribution

US distribution to states of: Illinois, Nebraska, & California

Key facts

Status
Ongoing
Initiation date
2022-08-12
Report date
2025-06-25
Voluntary/Mandated
Voluntary: Firm initiated
Location
Deer Park, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1984-2025