BEUDAMED
    FDA Recall Open, Classified

    META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690

    Recall: Z-1806-2025 · Initiated March 18, 2025

    Recall

    Recall Number
    Z-1806-2025
    Event Number
    96586
    Firm
    Smith & Nephew, Inc.
    FEI Number
    1020279
    Product Code
    HSB
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    March 18, 2025
    Posted
    May 19, 2025
    Address
    1450 E Brooks Rd, Memphis, TN, 38116-1804

    Description

    META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690

    Reason

    Integrated Lag/Compression Screw Kit has a compression screw with hexagon socket that may be undersized, which causes the screw to be non-functional, which would require replacement with another adequate size screw, and exchange may exceed 30 minutes.

    Action

    On 3/18/2025, recall notices were mailed and emailed to customers who were asked to do the following: 1) Inspect your inventory and locate any affected devices and quarantine them. 2) If you are a sales rep, district office, or distributor, you must notify your customers of the field action and ensure that the required actions are complete. 3) Complete and return the notice response section via email to [email protected] If you have any questions email the firm at the email address above.

    Distribution

    Worldwide - US Nationwide distribution in the states of FL, NH, TX, CA, OH, NY, AL, IA, MA, NV, MO, WA, LA, TN, NC, KY, NM, NJ, AZ and the country of ZA.

    Quantity

    75