BEUDAMED
    FDA Recall Terminated

    FHC 66-ZD-MD microTargeting Drive System: System for Stereotactic Positioning Used with the Power Assist (66-DA-ME) or Display Assembly (66-DA-EN)

    Recall: Z-0895-05 · Initiated March 14, 2005

    Recall

    Recall Number
    Z-0895-05
    Event Number
    31718
    Firm
    FHC, Inc.
    FEI Number
    3002250546
    Product Code
    HAW
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 14, 2005
    Posted
    June 16, 2005
    Terminated
    July 8, 2008
    Address
    9 Main St, Bowdoinham, ME, 04008-4418

    Description

    FHC 66-ZD-MD microTargeting Drive System: System for Stereotactic Positioning Used with the Power Assist (66-DA-ME) or Display Assembly (66-DA-EN)

    Reason

    Potential for non-sterile pin to contaminate sterile field

    Action

    FHC notified customers by letter dated 3/14/05 and 3/25/05. The firm has issued a temporary set of instructions which include covering the non-sterile engagement pin with sterile tape and an amended Instruction For Use page to all customers. A redesigned pulley cover which will be sent to all customer when it becomes available in April 2005.

    Distribution

    Natiowide

    Quantity

    169 units