BEUDAMED
    FDA Recall Open, Classified

    INTEGRA SURFIX ALPHA Screwdriver Torx 10, REF 219 135 ND

    Recall: Z-0548-2022 · Initiated January 4, 2022

    Recall

    Recall Number
    Z-0548-2022
    Event Number
    89382
    Firm
    Smith & Nephew, Inc.
    FEI Number
    1020279
    Product Code
    HRS
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    January 4, 2022
    Address
    1450 E Brooks Rd, Memphis, TN, 38116-1804

    Description

    INTEGRA SURFIX ALPHA Screwdriver Torx 10, REF 219 135 ND

    Reason

    The affected screwdrivers are out of specification and may not mate with the Surfix Alpha Lock screw

    Action

    The firm initiated the recall by letter and email on 01/04/2022. The letter requested that the consignee examine their inventory, quarantine all affected units, and return the completed response form. Entities who have further distributed the product were directed to notify their customers. The firm is seeking return of the product.

    Distribution

    US Nationwide distribution in the states of CA and OH.

    Quantity

    8 units (US)