BEUDAMED
    FDA Recall Terminated

    Biomet Spine Polaris 5.5 Button Lock Screw Inserter. Catalog Number 14-500178. The Polaris Spinal System is a non-cervical, pedicle screw spinal fixation device.

    Recall: Z-0954-2013 · Initiated February 7, 2013

    Recall

    Recall Number
    Z-0954-2013
    Event Number
    64452
    Firm
    Ebi, Llc
    FEI Number
    2242816
    Product Code
    HXX
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    February 7, 2013
    Posted
    March 15, 2013
    Terminated
    December 7, 2015
    Address
    100 Interpace Pkwy, Parsippany, NJ, 07054-1149

    Description

    Biomet Spine Polaris 5.5 Button Lock Screw Inserter. Catalog Number 14-500178. The Polaris Spinal System is a non-cervical, pedicle screw spinal fixation device.

    Reason

    Increased risk of failure at the driver tip during screw insertion or removal.

    Action

    Biomet Spine sent a "Urgent Medical Device Recall" notices dated February 6, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to immediately locate and remove affected items from circulation and return affected product to EBI, LLC. Please follow the instructions on the enclosed "FAX Back Response Form, " and fax a copy of the Response Form to (973) 257-0232, prior to return of the items. Questions related to this notice should be directed to (973) 299-9300 ex. 2322. Monday through Friday, 8am to 5pm.

    Distribution

    Nationwide Distribution including the states of AL, IN, MO, NE TN and TX.

    Quantity

    59 units.