BEUDAMED
    FDA Recall Terminated

    Apex Pilot Shaft 14.4mm

    Recall: Z-0716-04 · Initiated January 17, 2003

    Recall

    Recall Number
    Z-0716-04
    Event Number
    26157
    Firm
    Apex Surgical, LLC
    FEI Number
    3002757749
    Product Code
    HTO
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 17, 2003
    Posted
    July 20, 2004
    Terminated
    April 1, 2004
    Address
    12 Harding Street, Suite 202, Lakeville, MA, 02347

    Description

    Apex Pilot Shaft 14.4mm

    Reason

    Pilot shaft may break during reaming or broaching of the femur

    Action

    Apex Surgical notified accounts by letter on 1/17/03, advising users to discontinue use of the stem pilots and return the pilots, and associated broaches and reamers because they would not be interchangeable with the new design.

    Distribution

    CT, OH, FL, OK, TX, RI, NV, SC,

    Quantity

    45 units