BEUDAMED
    FDA Recall Terminated

    Genesis II, Cruciate Retaining, Oxinium, Femoral component, Size 5 right, Part No. 71420152

    Recall: Z-1157-06 · Initiated April 12, 2006

    Recall

    Recall Number
    Z-1157-06
    Event Number
    35492
    Firm
    Smith & Nephew Inc
    FEI Number
    1020279
    Product Code
    HSX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 12, 2006
    Posted
    June 17, 2006
    Terminated
    April 11, 2007
    Address
    1450 E Brooks Rd, Memphis, TN, 38116-1804

    Description

    Genesis II, Cruciate Retaining, Oxinium, Femoral component, Size 5 right, Part No. 71420152

    Reason

    Mispackaging-A size 5 femoral component, left, box had a size 5 right component in the box.

    Action

    All consignees were notified of the potential swap on 4/11/2006 via phone. The firm followed with a recall notice dated 05/18/2006.

    Distribution

    Worldwide-including states of LA, NC, IN, and countries of France, and Turkey

    Quantity

    3 units