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SURGIMESH WN, Polymeric Surgical Mesh, Large Flat Sheet… recallZ-1983-2025 · Chamberlain Technologies LLC · initiated Aug 12, 2022

Completed

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Chamberlain Technologies LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Potential presence of residual adhesive material on the mesh surface.

FDA root cause category: Process control

What the company is doing

Customer notification began 8/12/22. Initial communication was made directly (by phone and in-person visit). This communication instructed users to segregate and return the affected product to BG Medical. If you have any questions, call 8473044069 or email: [email protected].

Recall details

Recall number
Z-1983-2025
Status
Completed
Initiated by the company
Aug 12, 2022
Posted by the FDA
Jun 17, 2025
Recalling firm
Chamberlain Technologies LLC
Quantity
60 units
Product code
FTL
FDA submissions
K061445
Distribution
US distribution to states of: Illinois, Nebraska, & California

Product description

SURGIMESH WN, Polymeric Surgical Mesh, Large Flat Sheet, Model/Catalog Number: T3030

Code information (models, lots, serial numbers)

Lot Code: Reference Number: T3030 UDI: (01)00850011929186(17)250701(10)Z2459757F Lot Number: Z2459757F Expiration Date: 2025-07-01

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

1 device cleared under K061445 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 96930).

Sources and updates

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