BEUDAMED
    FDA Recall Terminated

    Small Halo Crown w/HI Skull pins, DePuy Spine Bremer Halo System Product Code: HT025HI

    Recall: Z-0135-2007 · Initiated October 10, 2006

    Recall

    Recall Number
    Z-0135-2007
    Event Number
    36504
    Firm
    DePuy Spine, Inc.
    FEI Number
    1526439
    Product Code
    HWC
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 10, 2006
    Posted
    November 2, 2006
    Terminated
    March 27, 2017
    Address
    325 Paramount Dr, Raynham, MA, 02767-5199

    Description

    Small Halo Crown w/HI Skull pins, DePuy Spine Bremer Halo System Product Code: HT025HI

    Reason

    Sterility of device is compromised due to loss of package integrity

    Action

    DePuy Spine notified US consignees by letter via FedEX on 10/10/06 addressed to Materials Management. Outside the US noitifcation made to DePuy Spine and Distributors, recalls will be conducted by the foreign subsidiaries.

    Distribution

    Nationwide and Australia, New Zealand, Germany, Canada, Czech Republic, Netherlands, Portugal, Sweden, UK, Japan, Indonesia, Italy, Belgium, Hong Kong, Poland, Spain, Switzerland, Taiwan, Turkey, Chile, Egypt, Guatemala, Hungary, Israel, Greece, Thailand, Mexico, Colombia, Venezuela, Slovenia

    Quantity

    2272 units