BEUDAMED
    FDA Enforcement Class II 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 · Reported April 18, 2018

    Enforcement

    Recall Number
    Z-1317-2018
    Event ID
    79515
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Smith & Nephew, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    April 18, 2018
    Initiation Date
    March 7, 2018
    Classification Date
    April 6, 2018
    Termination Date
    October 31, 2018
    Address
    1450 E Brooks Rd, Memphis, TN, 38116-1804, United States

    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.

    Code Info

    Lot Number 17GM04522

    Distribution

    US, Puerto Rico, Malaysia

    Quantity

    59 units