BEUDAMED
    FDA Enforcement Class II Terminated

    D-RAD, 2.4MMX 20MM, S.T. CORTEX SCREW, QTY: (1), STERILE R, RES 74682420 Orthopedic

    Recall: Z-1856-2017 · Reported April 26, 2017

    Enforcement

    Recall Number
    Z-1856-2017
    Event ID
    76729
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Smith & Nephew, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 26, 2017
    Initiation Date
    March 9, 2017
    Classification Date
    April 18, 2017
    Termination Date
    August 21, 2019
    Address
    1450 E Brooks Rd, N/A, Memphis, TN, 38116-1804, United States

    Description

    D-RAD, 2.4MMX 20MM, S.T. CORTEX SCREW, QTY: (1), STERILE R, RES 74682420 Orthopedic

    Reason

    The expiration dates on the labeling are incorrect, the actual expiration dates are before the date on the labeling.

    Code Info

    Batch number 14MM07780R

    Distribution

    Worldwide Distribution - US (Nationwide) Internationally to Colombia, Denmark, Finland, France, Great Britain, Italy, and Singapore

    Quantity

    100 units