BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated October 25, 2021

    Recall

    Recall Number
    Z-0265-2022
    Event Number
    88975
    Firm
    Smith & Nephew, Inc.
    FEI Number
    1020279
    Product Code
    HRS
    Status
    Open, Classified
    Root Cause
    Error in labeling
    Initiated
    October 25, 2021
    Address
    1450 E Brooks Rd, Memphis, TN, 38116-1804

    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.

    Action

    The recalling firm issued letters dated 10/25/2021 on the same day via email and FedEx overnight. The letter explained the issue and the potential risk of use of the product. Required actions were listed on the enclosed response form. The actions included inspecting their inventory and quarantining the affected product immediately and returning it. Distributors or sales representatives were to notify their customers of the field action and ensure the required actions are complete.

    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