BEUDAMED
    FDA Recall Terminated

    Halo Support Bracket Assembly (Part #438-B1010). The bracket is sold as a component of the BUDDE Halo Neurosurgical Retractor System, or sold as a separate component. The defective sub-assembly part is the Clamp Assembly (Part #438A1071), which is part of the Halo Bracket Assembly.

    Recall: Z-0781-03 · Initiated February 26, 2003

    Recall

    Recall Number
    Z-0781-03
    Event Number
    25715
    Firm
    Ohio Medical Instrument Co Inc
    FEI Number
    1525725
    Product Code
    GZT
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 26, 2003
    Posted
    April 25, 2003
    Terminated
    December 1, 2003
    Address
    4900 Charlemar Dr, Cincinnati, OH, 45227

    Description

    Halo Support Bracket Assembly (Part #438-B1010). The bracket is sold as a component of the BUDDE Halo Neurosurgical Retractor System, or sold as a separate component. The defective sub-assembly part is the Clamp Assembly (Part #438A1071), which is part of the Halo Bracket Assembly.

    Reason

    The component was manufactured with an insufficient weld that could break during use.

    Action

    The firm contacted their accounts by email and telephone on 2/26/2003.

    Distribution

    The units were shipped to domestic consignees in NY, NJ, IL, and FL; and to foreign customers located in Japan, Hong Kong, Korea, Great Britian, and Germany.

    Quantity

    43 components