BEUDAMED
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    FLEX-FOOT RE-FLEX VSP

    FDA Adverse Event
    Injury ·OSSUR NORTH AMERICA, INC.·Product code ISH·September 27, 2002

    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).

    FDA Enforcement
    Class II ·Terminated·Ossur North America Inc·November 27, 2013

    VSP Shock Module (as part of a prosthetic foot).

    FDA Recall
    Terminated ·Ossur North America Inc·Product code ISH·June 15, 2004

    Mauch XG, Caron Knee Frame. Model numbers FDM01804U, FRM01804LU, FRM01851U, FRM61750.

    FDA Recall
    Terminated ·Ossur North America Inc·Product code ISY·March 17, 2003

    Ossur Total Knee 1900, Model Number TK 1900, external prosthetic knee.

    FDA Recall
    Terminated ·Ossur North America Inc·Product code ISY·March 29, 2006

    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).

    FDA Recall
    Terminated ·Ossur North America Inc·Product code ISH·October 24, 2013

    Ossur Total Knee 2100, Model Number TK 2100, external prosthetic knee.

    FDA Recall
    Terminated ·Ossur North America Inc·Product code ISY·March 29, 2006

    Ossur Total Knee Junior, Model Number TK 1100, External Prosthetic knee.

    FDA Recall
    Terminated ·Ossur North America Inc·Product code ISY·March 29, 2006

    Ossur Total Knee 2000, Model Number TK 2000, external prosthetic knee.

    FDA Recall
    Terminated ·Ossur North America Inc·Product code ISY·March 29, 2006