BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-1984-2025 · Initiated August 12, 2022

    Recall

    Recall Number
    Z-1984-2025
    Event Number
    96930
    Firm
    Chamberlain Technologies LLC
    FEI Number
    3015860534
    Product Code
    FTL
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    August 12, 2022
    Posted
    June 17, 2025
    Address
    21805 W Field Pkwy, Deer Park, IL, 60010-3228

    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.

    Action

    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].

    Distribution

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

    Quantity

    20 units