FDA-Device2025-06-25Class II

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

Chamberlain Technologies LLC
Hazard

Potential presence of residual adhesive material on the mesh surface.

Sold states
US distribution to states of: Illinois, Nebraska, & California
Affected count
20 units
Manufactured in
21805 W Field Pkwy, N/A, Deer Park, IL, United States
Products
SURGIMESH XB, Polymeric Surgical Mesh, 14m x 15cm Flat Sheet with Silicone Barrier, Model/Catalog Number: Tintra R-1415

Official notice

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

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