BEUDAMED
    FDA Recall Terminated

    ARRAY and POLARIS Spinal System Medium Cross Connector Non Sterile Biomet Spine, Parsippany, NJ. 07054

    Recall: Z-0131-2011 · Initiated September 16, 2010

    Recall

    Recall Number
    Z-0131-2011
    Event Number
    56791
    Firm
    Ebi, Llc
    FEI Number
    2242816
    Product Code
    NKB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 16, 2010
    Posted
    October 22, 2010
    Terminated
    June 1, 2012
    Address
    100 Interpace Pkwy, Parsippany, NJ, 07054-1149

    Description

    ARRAY and POLARIS Spinal System Medium Cross Connector Non Sterile Biomet Spine, Parsippany, NJ. 07054

    Reason

    One of the two connector ends of the medium cross connector may not be fully secured to the rod after tightening. This may not be readily apparent to the operating surgeon, resulting in inadequate torsional stability.

    Action

    Biomet Spine issued an Urgent Medical Device Recall letter dated September 16, 2010 to distributors and physicians, identifying the affected device and actions to be taken. Customers and distributors were requested to identify, remove, and immediately return the affected product to Biomet, following enclosed Product Return Instructions, and complete and return the Removal Tracking and Verification Form. Customers and distributors can contact Biomet at 1-800-526-2579.

    Distribution

    Worldwide Distribution: USA and the countries of Australia, Columbia, Great Britain, The Netherlands, New Zealand, and Switzerland.

    Quantity

    82 units