BEUDAMED
    FDA Enforcement Class II Terminated

    Fixed Offset Adapter, A-642100. The Offset Adapter is a fixed modular component which sets the tube 14.5 mm (0.57 inch) offset from the center line of the pyramid. It is made of a high-strength alloy with a pyramid receiver and is intended where there is a need to offset the tube horizontally in relation to other components. It is fully compatible with all standard 30mm prosthetic pylons. (3) Offset: 14,5mm (0.57inch).

    Recall: Z-0362-2014 · Reported November 27, 2013

    Enforcement

    Recall Number
    Z-0362-2014
    Event ID
    66609
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ossur North America Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 27, 2013
    Initiation Date
    October 24, 2013
    Classification Date
    November 19, 2013
    Termination Date
    June 17, 2014
    Address
    27051 Towne Centre Dr, Foothill Ranch, CA, 92610-2804, United States

    Description

    Fixed Offset Adapter, A-642100. The Offset Adapter is a fixed modular component which sets the tube 14.5 mm (0.57 inch) offset from the center line of the pyramid. It is made of a high-strength alloy with a pyramid receiver and is intended where there is a need to offset the tube horizontally in relation to other components. It is fully compatible with all standard 30mm prosthetic pylons. (3) Offset: 14,5mm (0.57inch).

    Reason

    Ossur inititated a voluntary recall of the A-642100 Fixed Offset Adapter because it can develop fatigue cracks in normal use over an extended period of time and ultimately separate completely.

    Code Info

    Item Number: A-642100 All Serial Numbers.

    Distribution

    US Distribution including the states of AL, TX, NY, CA, VA, GA, WI, NC, ID and NJ.

    Quantity

    66 units