BEUDAMED
    FDA Recall Terminated

    Electronic Otto Bock Compact leg prosthesis System, 3C95/3C85, to be used exclusively for the exoprosthetic fitting of amputations of the lower limb. Microprocessor-controlled prosthetic knee joint used by lower extremity amputees.

    Recall: Z-0363-2007 · Initiated August 10, 2006

    Recall

    Recall Number
    Z-0363-2007
    Event Number
    36256
    Firm
    Bock, Otto, Orthopedic Ind, Inc Two Carlson
    FEI Number
    2182293
    Product Code
    KFX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 10, 2006
    Posted
    January 25, 2007
    Terminated
    November 26, 2008
    Address
    Parkway North, Suite 100, Minneapolis, MN, 55447

    Description

    Electronic Otto Bock Compact leg prosthesis System, 3C95/3C85, to be used exclusively for the exoprosthetic fitting of amputations of the lower limb. Microprocessor-controlled prosthetic knee joint used by lower extremity amputees.

    Reason

    A correction of the Otto Bock Compact prosthetic knee joint, material numbers 3C93 and 3C85, is being conducted. A limited number of Compacts have a defective solder connection between the contact wires and battery terminals. If exposed to strong vibrations these Compact knee joints have an increased probability of malfunction and a resultant risk to the Compact wearer.

    Action

    An Urgent Correction Notice, dated August 11, 2006, was sent to customers who purchased the Compact Prosthetic knee joint. The letter identifies affected units, asks for all in stock devices to be returned to Otto Bock, and for patients fitted with an affected device, a loaner knee will be provided as a temporary replacement while their device is serviced.

    Distribution

    Nationwide.

    Quantity

    176