FDA Enforcement
Class II
Ongoing
SURGIMESH XB, Polymeric Surgical Mesh, 14m x 15cm Flat Sheet with Silicone Barrier, Model/Catalog Number: Tintra R-1415
Recall: Z-1984-2025
·
Reported June 25, 2025
Enforcement
- Recall Number
- Z-1984-2025
- Event ID
- 96930
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Chamberlain Technologies LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- June 25, 2025
- Initiation Date
- August 12, 2022
- Classification Date
- June 17, 2025
- Address
- 21805 W Field Pkwy, N/A, Deer Park, IL, 60010-3228, United States
Description
SURGIMESH XB, Polymeric Surgical Mesh, 14m x 15cm Flat Sheet with Silicone Barrier, Model/Catalog Number: Tintra R-1415
Reason
Potential presence of residual adhesive material on the mesh surface.
Code Info
Lot Code: Reference Number: Tintra R-1415 UDI: (01)00850011929032(17)250701(10)Z2459695M Lot Number: Z2459695M Expiration Date: 2025-07-01
Distribution
US distribution to states of: Illinois, Nebraska, & California
Quantity
20 units