Device product

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

Z-1984-2025

August 12, 2022

Class II

Product summary

Firm: Chamberlain Technologies LLC
Event: Event 96930
Status: Ongoing
Classification: Class II
Quantity: 20 units
Official record key: device-enforcement:Z-1984-2025

Official wording

Reason: Potential presence of residual adhesive material on the mesh surface.

Code information: Lot Code: Reference Number: Tintra R-1415 UDI: (01)00850011929032(17)250701(10)Z2459695M Lot Number: Z2459695M Expiration Date: 2025-07-01

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

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Potential presence of residual adhesive material on the mesh surface.