BEUDAMED
    FDA Recall 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 · Initiated August 22, 2013

    Recall

    Recall Number
    Z-0359-2014
    Event Number
    66300
    Firm
    Ebi, Llc
    FEI Number
    2242816
    Product Code
    HWC
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    August 22, 2013
    Posted
    November 19, 2013
    Terminated
    August 31, 2016
    Address
    100 Interpace Pkwy, Parsippany, NJ, 07054-1149

    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.

    Action

    Urgent Product Information notices dated 8/22/2013 were mailed via FedEx to distributors on 8/23/2013. Follow-up emails with a copy of the UPI notice were sent to distributors on 8/23/2013. The UPI notice informed the customers of the issue with the product and how to identify the affected product. Customers were advised that the Polaris Translation Screw System and the SpF Implantable Spine Fusion Stimulator not be used in conjunction with any implants containing cobalt chrome. Firm contacts were provided in case customers had any questions. EBI, LLC had a conference call with their domestic distributors on 8/23/2013 informing them they are required to notify their customers.

    Distribution

    Nationwide distribution including Puerto Rico.

    Quantity

    7,092 units