BEUDAMED
    FDA Recall 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 · Initiated October 24, 2013

    Recall

    Recall Number
    Z-0362-2014
    Event Number
    66609
    Firm
    Ossur North America Inc
    FEI Number
    1000519909
    Product Code
    ISH
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 24, 2013
    Posted
    November 19, 2013
    Terminated
    June 17, 2014
    Address
    27051 Towne Centre Dr, Foothill Ranch, CA, 92610-2804

    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.

    Action

    Ossur sent an "Safety Notice Voluntary Product Recall" letter dated October 29, 2013, via regular mail. Follow-up telephones are also made. The letter identified the product the problem and the actions to be taken by the customer. ssur is committed to providing superior customer service and we will do our utmost to minimize any inconvenience this may cause your practice. To ensure patient safety we kindly ask you to take the following action: " Please identify the users of each of the A-642100 adapters, see attached list. " Also, please check your inventory for any A-642100s you may have on hand but have not fitted on users. A follow-up phone call will be made a few days later to coordinate replacements. A new replacement component will be provided to the customer. For further questions please call (949) 360-3634.

    Distribution

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

    Quantity

    66 units