BEUDAMED
    FDA Recall Terminated

    M/DN Intramedullary Fixation Humeral Nail

    Recall: Z-1004-04 · Initiated March 16, 2004

    Recall

    Recall Number
    Z-1004-04
    Event Number
    28623
    Firm
    Zimmer Inc.
    FEI Number
    1000220733
    Product Code
    HSB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 16, 2004
    Posted
    July 20, 2004
    Terminated
    July 2, 2004
    Address
    345 E Main St, Warsaw, IN, 46580-2746

    Description

    M/DN Intramedullary Fixation Humeral Nail

    Reason

    One and possibly more units in the lot have the proximal angled hole oriented 180 degrees reversed from the required orientation.

    Action

    Units were distributed to twelve (12) consignees in the US and seven (7) foreign consignees (China, Japan, Korea, El Salvador, Singapore, Taiwan and UK)

    Quantity

    33 units