BEUDAMED
    FDA Enforcement Class II Terminated

    Smith & Nephew Dyonics Saw Blade, Short, Narrow, Product Number 3704

    Recall: Z-1242-2017 · Reported March 1, 2017

    Enforcement

    Recall Number
    Z-1242-2017
    Event ID
    76414
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Smith & Nephew, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 1, 2017
    Initiation Date
    February 2, 2017
    Classification Date
    February 22, 2017
    Termination Date
    September 20, 2019
    Address
    1450 E Brooks Rd, N/A, Memphis, TN, 38116-1804, United States

    Description

    Smith & Nephew Dyonics Saw Blade, Short, Narrow, Product Number 3704

    Reason

    The single use devices are provided sterile and do not have an expiration date on the label.

    Code Info

    Batch Numbers: 50525150 50386077 50261802 50197616 50178740 50171398 50158656 50138050 50121538 50103379 50089298 50082582 50061131

    Distribution

    Nationwide Foreign: Brazil, Canada, Chile , China, Denmark, Hong Kong, India, Mexico, Peru, Singapore, Venezuela

    Quantity

    8748