BEUDAMED
    FDA Recall Terminated

    Axial Torque Limiting Driver (1st generation) Product Usage: The Bradshaw Medical Axial Torque Limiting Driver is a reusable surgical instrument designed to limit the magnitude of applied (input) torque transferred to an external (output) device or fastener in the clockwise direction. The device is a non-adjustable mechanical click style hand torque tool which presents an audible and tactile click when the maximum desired torque is reached.

    Recall: Z-1637-2016 · Initiated February 2, 2015

    Recall

    Recall Number
    Z-1637-2016
    Event Number
    73873
    Firm
    Bradshaw Medical Inc.
    FEI Number
    3006846753
    Product Code
    HXC
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    February 2, 2015
    Posted
    May 10, 2016
    Terminated
    January 10, 2020
    Address
    10325 58th Pl, Kenosha, WI, 53144-7872

    Description

    Axial Torque Limiting Driver (1st generation) Product Usage: The Bradshaw Medical Axial Torque Limiting Driver is a reusable surgical instrument designed to limit the magnitude of applied (input) torque transferred to an external (output) device or fastener in the clockwise direction. The device is a non-adjustable mechanical click style hand torque tool which presents an audible and tactile click when the maximum desired torque is reached.

    Reason

    A component failure could cause a situation where the applied torque was significantly higher than the calibrated torque setting.

    Action

    Consignees were sent a Bradshaw Medical "Product Withdrawal Notice" letter, date marked starting February 2, 2015. The letter specified the Part Number, Lot Number (s) and Shipped date for each consignee. The letter described the product and advised consignees to discontinue use of the product. Requested consignees to complete and return the Customer /Distribution verification Form to BMI Regulatory Affairs FAX (262) 925-1380 and to further send the "Withdrawal Notice and Customer Verification Form" to all customers to whom they have distributed the product.

    Distribution

    US Nationwide Distribution in the states of: CA, FL, IN, MA, MI, OH, PA, TN UT, VA and the country of UNITED KINGDOM

    Quantity

    3,760 units