BEUDAMED
    FDA Recall Open, Classified

    TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number DWJ318

    Recall: Z-1237-2026 · Initiated December 19, 2025

    Recall

    Recall Number
    Z-1237-2026
    Event Number
    98123
    Firm
    Tornier, Inc
    FEI Number
    3000718467
    Product Code
    KWS
    Status
    Open, Classified
    Root Cause
    Labeling mix-ups
    Initiated
    December 19, 2025
    Posted
    February 2, 2026
    Address
    10801 Nesbitt Ave S, Bloomington, MN, 55437-3109

    Description

    TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number DWJ318

    Reason

    A specific lot of screws is incorrectly labeled. Screws are labeled as 5.0mmx18mm but actual screws are 5.00mmx14mm. If mismatch is detected during surgery, the issue may cause a minor delay in surgery. If not detected and incorrect screw is used, issue may increase risk of earlier mechanical failure, loosening, and need for revision surgery.

    Action

    On December 19, 2025, the firm began notifying affected customers via Urgent Field Safety Notice letters. Customers were instructed to immediately check their internal inventory for affected product. Firm stated that return of product is not necessary because the issue is detectable pre-operatively. The physical product itself is correctly marked, and after unpacking, should only be assigned to the correct place in the screw caddy. The notification is being provided for awareness only.

    Distribution

    US Nationwide distribution.

    Quantity

    427