BEUDAMED
    FDA Recall Terminated

    D-RAD Self-Tapping Locking Screw intended for the fixation of fractures involving the distal radius. smith&nephew D-RAD 2.4MM X 10MM S-T LOCKING SCREW, REF 74692410, QTY (1), STERILE R

    Recall: Z-1317-2018 · Initiated March 7, 2018

    Recall

    Recall Number
    Z-1317-2018
    Event Number
    79515
    Firm
    Smith & Nephew, Inc.
    FEI Number
    1020279
    Product Code
    HWC
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    March 7, 2018
    Posted
    March 20, 2018
    Terminated
    October 31, 2018
    Address
    1450 E Brooks Rd, Memphis, TN, 38116-1804

    Description

    D-RAD Self-Tapping Locking Screw intended for the fixation of fractures involving the distal radius. smith&nephew D-RAD 2.4MM X 10MM S-T LOCKING SCREW, REF 74692410, QTY (1), STERILE R

    Reason

    One lot of D-RAD Self-Taping Locking Screws used with the Distal Radius Fracture Kit were machined out of specification. Screws measured over tolerance within the head thread form by 0.002-0.003 inch.

    Action

    The firm initiated their recall by letter and email on 03/07/2018. The firm requested return of the product.

    Distribution

    US, Puerto Rico, Malaysia

    Quantity

    59 units