BEUDAMED
    FDA Recall Terminated

    VKS Knee System; VKS Distal Femoral Resection Guide, Model Number 1214122, Revisions A and B. (Re-usable surgical instrument)

    Recall: Z-0397-06 · Initiated December 2, 2005

    Recall

    Recall Number
    Z-0397-06
    Event Number
    34255
    Firm
    Plus Orthopedics USA
    FEI Number
    3001237832
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 2, 2005
    Posted
    January 18, 2006
    Terminated
    January 29, 2007
    Address
    10188 Telesis Ct, San Diego, CA, 92121-4779

    Description

    VKS Knee System; VKS Distal Femoral Resection Guide, Model Number 1214122, Revisions A and B. (Re-usable surgical instrument)

    Reason

    The adjustment knob tower on one device was found to have broken off from the body of the instrument. This did not happend during a surgery and is believed to have been caused by the instrument being dropped or otherwise mishandled during hospital processing. A manufacturer evaluation of the device determined that the laser weld attaching the knob to the body was not to specification.

    Action

    The adjustment know tower on one device was found t have broken off from the body of the instrument. This did not happend during a surgery, and is belived tohave been caused by the instrument being dropped or otherwise mishandled during hospital processing. A manufacturer evaluation of the device determined that the laser weld attaching the knob to the body was not to specification.

    Distribution

    Arizona, California, Colorado, Idaho, New York, Oklahoma, Texas, Utah, Wisconsin

    Quantity

    14