15 results
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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The SYMBIONIC LEG is an integrated prosthetic leg for transfemoral and knee disarticulation amputees. Product Usage: SYMBIONIC LEG is intended for continuous use by amputees of low to moderate impact levels that weigh less than 125 kg for foot categories 25 30 and less than 100kg for foot categories 22, 23 and 24. The system is not intended for athletic use.
FDA Recall
Terminated
·Ossur Americas, Inc.·October 15, 2012
The Symbionic Leg is an integrated prosthetic leg for transfemoral and knee disarticulation amputees. The prosthesis is composed of the RHEO KNEE and the PROPRIO FOOT, both already existing products from ssur. Both are a battery powered micro-processor controlled prosthetic device and are connected through a shared battery. The knee and the foot have different sensor systems that provide real-time information used to control knee joint resistance and the flexion/extension of the ankle during the gait cycle. Default control parameters are provided with the device but can be manually adjusted by a certified prosthetist through software (knee), or by a certified prosthetist or the user through controls on the device itself (foot). SYMBIONIC LEG is intended for continuous use by amputees of low to moderate impact levels that weigh less than 125 kg for foot categories 25 30 and less than 100kg for foot Categories 22, 23 and 24. The system is not intended for athletic use.
FDA Recall
Terminated
·Ossur Americas, Inc.·Product code ISH·February 12, 2012
The Symbionic Leg is an integrated prosthetic leg for transfemoral and knee disarticulation amputees. The prosthesis is composed of the RHEO KNEE and the PROPRIO FOOT, both already existing products from ¿ssur. Both are a battery powered micro-processor controlled prosthetic device and are connected through a shared battery. The knee and the foot have different sensor systems that provide real-time information used to control knee joint resistance and the flexion/extension of the ankle during the gait cycle. Default control parameters are provided with the device but can be manually adjusted by a certified prosthetist through software (knee), or by a certified prosthetist or the user through controls on the device itself (foot). SYMBIONIC LEG is intended for continuous use by amputees of low to moderate impact levels that weigh less than 125 kg for foot categories 25 30 and less than 100kg for foot Categories 22, 23 and 24. The system is not intended for athletic use.
FDA Enforcement
Class II
·Terminated·Ossur Americas, Inc.·February 12, 2014
The SYMBIONIC LEG is an integrated prosthetic leg for transfemoral and knee disarticulation amputees. Product Usage: SYMBIONIC LEG is intended for continuous use by amputees of low to moderate impact levels that weigh less than 125 kg for foot categories 25 30 and less than 100kg for foot categories 22, 23 and 24. The system is not intended for athletic use.
FDA Enforcement
Class II
·Terminated·Ossur Americas, Inc.·March 5, 2014
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
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
FAST Procedure Kit. Intended for use as a Minor Surgical Procedures Tray.
FDA Enforcement
Class II
·Terminated·American Optisurgical Inc·June 12, 2013
Sysmex XN-Series Fluorocell PLT, Catalog #CD994563. Distributed in the U.S.A. by Sysmex America, Inc., Lincolnshire, IL. Fluorocell PLT is used to stain platelets in a diluted blood sample for the counting of platelets with the Sysmex XN-Series automated hematology analyzers.
FDA Recall
Terminated
·Sysmex America, Inc.·Product code KQC·July 27, 2018
ABL90 FLEX analyzers with software versions 3.3MR1 or below. The ABL90 FLEX Analyzer is a portable, automated Analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood. It is intended for use in a laboratory environment, near patient or point-of-care setting.
FDA Recall
Terminated
·Radiometer America Inc·Product code JJE·May 25, 2018