BEUDAMED
    FDA Recall Terminated

    VKS PE Tibia Insert Ultra-Congruent; Left, Size 2, 12mm; Model Number: 0214612; Plus Orthopedics, San Diego, CA 92121

    Recall: Z-0361-2008 · Initiated November 13, 2006

    Recall

    Recall Number
    Z-0361-2008
    Event Number
    45480
    Firm
    Plus Orthopedics USA
    FEI Number
    3001237832
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    November 13, 2006
    Posted
    December 8, 2007
    Terminated
    December 13, 2007
    Address
    10188 Telesis Ct, San Diego, CA, 92121-4779

    Description

    VKS PE Tibia Insert Ultra-Congruent; Left, Size 2, 12mm; Model Number: 0214612; Plus Orthopedics, San Diego, CA 92121

    Reason

    Labeling Error: The VKS PE Ultra-congruent insert package, may actually contain a Standard PE insert.

    Action

    Consignees were notified by telephone on 11/13/2006 to check their inventory and return any affected units. On 11/28/06 Physician Notifications and Patient Assessment forms were sent to the two physicians who had implanted a total of 4 devices.

    Distribution

    Nationwide: USA including states of ID, NY, VA & WI

    Quantity

    10