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Recall Observatory FDA recall evidence

Device product

SURGIMESH WN, Polymeric Surgical Mesh, 14cm x 15cm Flat Sheet, Model/Catalog Number: T1415

Z-1986-2025

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-1986-2025

Official wording

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

Code information: Lot Code: Reference Number: T1415 UDI: (01)00850011929155(17)250701(10)Z2459757H Lot Number: Z2459757H 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.