BEUDAMED
    FDA Recall Terminated

    Product is Anspach eMax Drill System console, catalog numbers SC-1000 and SC-1000-1 (does not include the related drill motor, foot-pedal control, motor attachments or drills/burrs)

    Recall: Z-1243-03 · Initiated April 23, 2003

    Recall

    Recall Number
    Z-1243-03
    Event Number
    26308
    Firm
    The Anspach Effort, Inc.
    FEI Number
    1045834
    Product Code
    HBC
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 23, 2003
    Posted
    October 15, 2003
    Terminated
    September 22, 2003
    Address
    4500 Riverside Dr., Palm Beach Gardens, FL, 33410

    Description

    Product is Anspach eMax Drill System console, catalog numbers SC-1000 and SC-1000-1 (does not include the related drill motor, foot-pedal control, motor attachments or drills/burrs)

    Reason

    Faulty component causing a malfunction which would unexpectedly shutdown the drill system and user may not be able to restart.

    Action

    A recall notification letter was mailed to domestic consignees and faxed to international consignees on April 23, 2003. The letter requests return of the devices.

    Distribution

    The devices were distributed to 12 domestic hosptials in FL, GA, NC, TX, CA, MA, MS as well as three international accounts in Taiwan, South Africa and Italy.

    Quantity

    24