BEUDAMED
    FDA Enforcement Class II Ongoing

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

    Recall: Z-1806-2025 · Reported May 28, 2025

    Enforcement

    Recall Number
    Z-1806-2025
    Event ID
    96586
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Smith & Nephew, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 28, 2025
    Initiation Date
    March 18, 2025
    Classification Date
    May 19, 2025
    Address
    1450 E Brooks Rd, N/A, Memphis, TN, 38116-1804, United States

    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.

    Code Info

    UDI-DI: 00885556132975. Lot: 24CT81426. Expiration: 25-Mar-2034

    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