9 results
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56ms
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Sources: EU EUDAMED, US FDA
OTTO BOCK
FDA Adverse Event
Injury
·OTTO BOCK ORTHOPEDIC INDUSTRY, INC.·Product code ISY·October 28, 1998
SYSTEM COVERED BALE LOCK KNEE JOINT
FDA Adverse Event
Malfunction
·OTTO BOCK ORTHOPEDIC INDUSTRY, INC.·Product code ISW·June 19, 1998
OTTO BOCK TUBE ADAPTER (TITANIUM 30MM ALUMINUM ALOE TUBE)
FDA Adverse Event
Injury
·OTTO BOCK, ORTHOPEDIC INDUSTRY, INC.·Product code ISH·February 1, 1996
21Y14 PushValve Product Usage: The PushValves/ MagValves is intended exclusively for the prosthetic fitting of lower limb amputees. The valve is a threadless one-way valve. It is used to evacuate air from the prosthetic socket.
FDA Enforcement
Class II
·Terminated·Ottobock Orthopedic Industrie·February 20, 2019
21Y14=S PushValve upper part Product Usage: The PushValves/ MagValves is intended exclusively for the prosthetic fitting of lower limb amputees. The valve is a threadless one-way valve. It is used to evacuate air from the prosthetic socket.
FDA Enforcement
Class II
·Terminated·Ottobock Orthopedic Industrie·February 20, 2019
21Y15 MagValve Product Usage: The PushValves/ MagValves is intended exclusively for the prosthetic fitting of lower limb amputees. The valve is a threadless one-way valve. It is used to evacuate air from the prosthetic socket.
FDA Enforcement
Class II
·Terminated·Ottobock Orthopedic Industrie·February 20, 2019
21Y15 MagValve Product Usage: The PushValves/ MagValves is intended exclusively for the prosthetic fitting of lower limb amputees. The valve is a threadless one-way valve. It is used to evacuate air from the prosthetic socket.
FDA Recall
Terminated
·Ottobock Orthopedic Industrie Max-Nader Str 15 D-37ns Duderstadt Germany·Product code ISY·January 10, 2019
21Y14 PushValve Product Usage: The PushValves/ MagValves is intended exclusively for the prosthetic fitting of lower limb amputees. The valve is a threadless one-way valve. It is used to evacuate air from the prosthetic socket.
FDA Recall
Terminated
·Ottobock Orthopedic Industrie Max-Nader Str 15 D-37ns Duderstadt Germany·Product code ISY·January 10, 2019
21Y14=S PushValve upper part Product Usage: The PushValves/ MagValves is intended exclusively for the prosthetic fitting of lower limb amputees. The valve is a threadless one-way valve. It is used to evacuate air from the prosthetic socket.
FDA Recall
Terminated
·Ottobock Orthopedic Industrie Max-Nader Str 15 D-37ns Duderstadt Germany·Product code ISY·January 10, 2019