BEUDAMED
    FDA Recall Terminated

    Detachable T-handle (Orthopedic Manual Surgical Instrumentation) Catalog Number 803-00-047 Revision G

    Recall: Z-0328-06 · Initiated October 21, 2005

    Recall

    Recall Number
    Z-0328-06
    Event Number
    33988
    FEI Number
    1000116912
    Product Code
    LXH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 21, 2005
    Posted
    December 28, 2005
    Terminated
    April 16, 2008
    Address
    9800 Metric Blvd, Encore Medical, Lp, Austin, TX, 78758

    Description

    Detachable T-handle (Orthopedic Manual Surgical Instrumentation) Catalog Number 803-00-047 Revision G

    Reason

    Detachable T-handles used in hip instrument sets and shoulder instrument sets may fail during shipment or upon initial use because they were incorrectly assembled.

    Action

    The firm initiated the recall on 10/21/05 via letter to all consignees.

    Distribution

    Device distributed nationwide to direct accounts in AZ, CA, FL, GA, IA, IL, KS, LA, MA, MD, MI, MO, MT, NM, NH, NJ, OK, OH, PA, SC, SD, TX, UT, VA, and WA. Foreign distribution to Saudi Arabia, Japan and Germany.

    Quantity

    141 units.