BEUDAMED
    FDA Enforcement Class II Terminated

    DePuy Synthes Radiolucent Retractor, part number 387.580, lot number 3620715

    Recall: Z-0092-2015 · Reported October 29, 2014

    Enforcement

    Recall Number
    Z-0092-2015
    Event ID
    69432
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Synthes, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 29, 2014
    Initiation Date
    October 2, 2014
    Classification Date
    October 20, 2014
    Termination Date
    December 18, 2015
    Address
    1302 Wrights Ln E, West Chester, PA, 19380-3417, United States

    Description

    DePuy Synthes Radiolucent Retractor, part number 387.580, lot number 3620715

    Reason

    Particle residue on the instrument from adhesive tape which was used to bind the device during transport. There may be a risk of tissue reaction if a patient is exposed to latex particles from the adhesive tape, or a systemic reaction such as anaphylaxis in patients with latex allergy.

    Code Info

    Radiolucent Retractor for Upper Cervical Spine part number 387.580, lot number 3620715.

    Distribution

    US Distribution including the states of PA, NC, TN, NY, WI, WA and MI.

    Quantity

    11