BEUDAMED
    FDA Recall Terminated

    BOLD/INI-CLIP 2.2mm Drill Bit with AO Attachment.

    Recall: Z-0466-2007 · Initiated November 10, 2006

    Recall

    Recall Number
    Z-0466-2007
    Event Number
    36868
    Firm
    Integra LifeSciences Corp.
    FEI Number
    3003418325
    Product Code
    HTW
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 10, 2006
    Posted
    January 9, 2007
    Terminated
    April 16, 2008
    Address
    311 Enterprise Dr, Plainsboro, NJ, 08536-3344

    Description

    BOLD/INI-CLIP 2.2mm Drill Bit with AO Attachment.

    Reason

    Incorrect drill length-Cannulated drill bits were manufactured to incorrect specifications (shorter length) resulting in inadequate preparation of bone prior to insertion of the UNI-CLIP Staple.

    Action

    An Urgent Recall Notice was sent on 11/10/2006 to both hospitals/distributors and sales representatives by first class mail.

    Distribution

    Nationwide to distributors, hospitals and Integra Sales Reps.

    Quantity

    107 in US.