BEUDAMED
    FDA Recall Terminated

    Otto Bock Modular Knee Joint, 3R66, Otto Bock HealthCare GmbH, Max-Nader-StraBe 15 . 37115 Duderstadt /Germany. Pediatric Prosthetic Device used by Lower Limb amputees.

    Recall: Z-0537-2010 · Initiated October 28, 2008

    Recall

    Recall Number
    Z-0537-2010
    Event Number
    50486
    Firm
    Bock, Otto, Orthopedic Ind, Inc Two Carlson
    FEI Number
    2182293
    Product Code
    ISY
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    October 28, 2008
    Posted
    December 16, 2009
    Terminated
    December 10, 2011
    Address
    Parkway North, Suite 100, Minneapolis, MN, 55447

    Description

    Otto Bock Modular Knee Joint, 3R66, Otto Bock HealthCare GmbH, Max-Nader-StraBe 15 . 37115 Duderstadt /Germany. Pediatric Prosthetic Device used by Lower Limb amputees.

    Reason

    Otto Bock Health Care LP has discovered that in some cases, the securing screws of the joint axes may not have been properly mounted. This can cause the axes to gradually move out of the joint and result in a risk of falling for the user.

    Action

    Consignees were sent on 10/28/08 a Otto Bock "Urgent: Correction Notice" letter dated October 27, 2008. The letter described the product and problem. It provided instructions if the product was in stock and instructed the consignee to contact the patients (a patient letter was provided) and to complete and return the reply card. Consignees were to contact Otto Bock at their Customer Service to request a return authorization.

    Distribution

    The product was only distributed within the US by the US company. Any OUS distribution was handled by the manufacturer in Germany.

    Quantity

    9