SURGIMESH XB, Polymeric Surgical Mesh, 14m x 15cm Flat Sheet with Silicone Barrier, Model/Catalog Number: Tintra R-1415
Summary
The FDA issued a Class II for SURGIMESH XB, Polymeric Surgical Mesh, 14m x 15cm Flat Sheet with Silicone Barri by Chamberlain Technologies LLC. Reason: Potential presence of residual adhesive material on the mesh surface..
Details
Source
Device Recall
External ID
Z-1984-2025
Action Date
2025-06-25
Status
Ongoing
Category
device
Product Description
SURGIMESH XB, Polymeric Surgical Mesh, 14m x 15cm Flat Sheet with Silicone Barrier, Model/Catalog Number: Tintra R-1415
Lot/Code Info: Lot Code: Reference Number: Tintra R-1415 UDI: (01)00850011929032(17)250701(10)Z2459695M Lot Number: Z2459695M Expiration Date: 2025-07-01
Quantity Affected: 20 units
Reason for Recall
Potential presence of residual adhesive material on the mesh surface.
Distribution
US distribution to states of: Illinois, Nebraska, & California
Type: Voluntary: Firm initiated
Recall Initiated: 2022-08-12
Company
Deer Park, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 167 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Chamberlain Technologies LLC has 4 FDA actions in our database, including 4 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Chamberlain Technologies LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Chamberlain Technologies LLC have FDA actions?
Chamberlain Technologies LLC has 4 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1984-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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