BEUDAMED
    FDA Recall Terminated

    ROC Lumbar bolt caddy, Part Number: 81997-01-05. Sterilization container for ROC bolts/screws. Product is used to contain spinal implants.

    Recall: Z-0036-2010 · Initiated December 16, 2008

    Recall

    Recall Number
    Z-0036-2010
    Event Number
    52760
    Firm
    Alphatec Spine, Inc.
    FEI Number
    2027467
    Product Code
    LRP
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    December 16, 2008
    Posted
    October 8, 2009
    Terminated
    November 13, 2009
    Address
    5818 El Camino Real, Carlsbad, CA, 92008-8816

    Description

    ROC Lumbar bolt caddy, Part Number: 81997-01-05. Sterilization container for ROC bolts/screws. Product is used to contain spinal implants.

    Reason

    Alphatec discovered that the lot of bolt caddies had the incorrect bolt length laser etched on one side of the caddy. The actual ROC bolts themselves are correctly laser etched.

    Action

    Alphatec contacted consignees via phone on December 16, 2008 and informed consignees that they will arrange to have Federal Express contact them for pick-up. Consignees were asked to check their inventory to see where this product is located, and ensure that it is put on hold for return; and what days and hours they are in the office, (Confirm address: attach copy of the pick-up request form.) If they have any follow up questions, they were told to call 1-800-922-1356.

    Distribution

    Nationwide Distribution -- Including states of TX, FL, & NJ.

    Quantity

    7 Screws