BEUDAMED
    FDA Enforcement Class II Terminated

    BIOMET Spine, 5.5 TI 5.5x50mm Translation Screw Polaris 5.5 TI Spinal System. Rx Only. Non-Sterile. Intended for immobilization and stabilization as an adjunct to fusion as a pedicle screw fixation system

    Recall: Z-0359-2014 · Reported November 27, 2013

    Enforcement

    Recall Number
    Z-0359-2014
    Event ID
    66300
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ebi, Llc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 27, 2013
    Initiation Date
    August 22, 2013
    Classification Date
    November 19, 2013
    Termination Date
    August 31, 2016
    Address
    100 Interpace Pkwy, Parsippany, NJ, 07054-1149, United States

    Description

    BIOMET Spine, 5.5 TI 5.5x50mm Translation Screw Polaris 5.5 TI Spinal System. Rx Only. Non-Sterile. Intended for immobilization and stabilization as an adjunct to fusion as a pedicle screw fixation system

    Reason

    Polaris Translation Screw Failures were recently reported to Biomet Spine. These failures are generally described as dissociation of the screw head from the shaft of the Polaris Translation Screw.

    Code Info

    Multiple Item and Lot numbers. The firm expects all Translation Screw Systems (containing a cobalt chrome component) used and contacted with the SpF Implantable Spine Fusion Stimulator (DC electrical current) to be at risk for this failure mode.

    Distribution

    Nationwide distribution including Puerto Rico.

    Quantity

    7,092 units