BEUDAMED
    FDA Enforcement Class II Terminated

    Smith & Nephew Dyonics Saw Blade, Standard, Product Number 3701

    Recall: Z-1239-2017 · Reported March 1, 2017

    Enforcement

    Recall Number
    Z-1239-2017
    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, Standard, Product Number 3701

    Reason

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

    Code Info

    Batch Numbers: 50586138 50458123 50418120 50339534 50306882 50285907 50248565 50231427 50197615 50171397 50158655 50138049 50119457 50089297 50082581 50069485

    Distribution

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

    Quantity

    2646