BEUDAMED
    FDA Recall Terminated

    Codman ICP Skull Bolt Kit, Product Code: 82-6638. Single Use, disposable drill kit for gaining access to the cranium to allow for insertion and retention of intracranial cranial pressure sensor, included in the kit.

    Recall: Z-1279-2012 · Initiated February 9, 2012

    Recall

    Recall Number
    Z-1279-2012
    Event Number
    61205
    Firm
    Codman & Shurtleff, Inc.
    FEI Number
    3002947440
    Product Code
    GWM
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    February 9, 2012
    Posted
    March 22, 2012
    Terminated
    September 11, 2015
    Address
    325 Paramount Drive, Raynham, MA, 02767

    Description

    Codman ICP Skull Bolt Kit, Product Code: 82-6638. Single Use, disposable drill kit for gaining access to the cranium to allow for insertion and retention of intracranial cranial pressure sensor, included in the kit.

    Reason

    Codman ICP Skull Bolt wrench is out of specification and cannot be used to turn the screw on the drill

    Action

    Codman issued "Urgent - Voluntary Product Recall Notification" letters on 2/9/12 via Fedx in the US and requested accounts examine inventory and return product. An Acknowledgement Form was requested to be returned. Outside the US affiliates were notified to recall to their accounts. Questions were directed to Customer Service (800) 225-0460.

    Distribution

    Worldwide Distribution - USA, and the countries of Canada, Austria, Brazil, Belgium, Columbia, China, Denmark, Estonia, Spain, Finland, France, Great Britain, Germany, India, Italy, Japan, Lithuania, Netherlands, New Zealand, Oman, Mexico, Portugal, Russia, Singapore, SIovenia, and Switzerland.

    Quantity

    4056 kits