BEUDAMED
    FDA Enforcement Class II Ongoing

    Smith and Nephew EVOS Self-Tapping Locking Screw SST: (1)REF 72413575, 3.5MM x 75MM, and (2) REF 72413570, 3.5MM X 70MM. Sterile.

    Recall: Z-0265-2022 · Reported November 24, 2021

    Enforcement

    Recall Number
    Z-0265-2022
    Event ID
    88975
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Smith & Nephew, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 24, 2021
    Initiation Date
    October 25, 2021
    Classification Date
    November 18, 2021
    Address
    1450 E Brooks Rd, N/A, Memphis, TN, 38116-1804, United States

    Description

    Smith and Nephew EVOS Self-Tapping Locking Screw SST: (1)REF 72413575, 3.5MM x 75MM, and (2) REF 72413570, 3.5MM X 70MM. Sterile.

    Reason

    The labels on the packages of screws were switched.

    Code Info

    REF 72413575 - batch #21FM24289; REF 72413570 - batch #21GM04743.

    Distribution

    Distribution was made to AL, AZ, CA, CO, CT, FL, GA, IL, IN, KY, LA, MA, ME, MI, MN, MO, NC, NJ, NY, OH, OR, PA, TN, TX, and WA. There was no direct government distribution. There was no military distribution. Foreign distribution was made to Australia, Canada, China, Dubai/MENA, Germany, Italy, Japan, Netherlands, Singapore, and Thailand.

    Quantity

    224 units