12 results
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53ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
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Navitrack System - OS Knee Universal, Orthopedic Stereotaxic Instrument
FDA Recall
Terminated
·Orthosoft, Inc. dba Zimmer CAS·Product code HAW·June 20, 2008
Navitrack System - OS Knee Universal, Stereotaxic instrument
FDA Recall
Terminated
·Orthosoft, Inc. dba Zimmer CAS·Product code HAW·October 28, 2008
Navitrack System - OS Knee Universal, Orthopedic Stereotaxic Instrument CAS Software application intended to assist in the placement of total knee replacement components
FDA Recall
Terminated
·Orthosoft, Inc. dba Zimmer CAS·Product code OLO·October 6, 2011
Sesamoid Plasty, Stereotaxic Instrument The Sesamoid Plasty workstation is used to run the tracking software as part of the software based navigation systems. The affected Sesamoid Plasty components are the central structural column and its base that hold up the computer and the tracking camera on the Sesamoid Plasty workstation. They are also designed to be disassembled such that the column can be folded onto itself for ease of transport after use. This is a retrospective recall report for a removal initiated on 17 June 2008
FDA Recall
Terminated
·Orthosoft, Inc. dba Zimmer CAS·Product code HAW·June 4, 2008
NDI P7 Position Sensor, Stereotaxic Instrument
FDA Recall
Terminated
·Orthosoft, Inc. dba Zimmer CAS·Product code HAW·June 9, 2009
SmartTools Knee System Orthopedic Stereotaxic Instrument
FDA Recall
Terminated
·Orthosoft, Inc. dba Zimmer CAS·Product code OLO·February 20, 2017
Navitrack¿ System - OS Knee Universal, Orthopedic Stereotaxic Instrument
FDA Enforcement
Class III
·Terminated·Orthosoft, Inc. dba Zimmer CAS·May 24, 2017
SmartTools Knee System Orthopedic Stereotaxic Instrument
FDA Enforcement
Class II
·Terminated·Orthosoft, Inc. dba Zimmer CAS·April 26, 2017
Navitrack System - OS Knee Universal, Orthopedic Stereotaxic Instrument CAS Software application intended to assist in the placement of total knee replacement components
FDA Enforcement
Class II
·Terminated·Orthosoft, Inc. dba Zimmer CAS·May 3, 2017
Navitrack System - OS Knee Universal, Stereotaxic instrument
FDA Enforcement
Class II
·Terminated·Orthosoft, Inc. dba Zimmer CAS·May 24, 2017
Sesamoid Plasty, Stereotaxic Instrument The Sesamoid Plasty workstation is used to run the tracking software as part of the software based navigation systems. The affected Sesamoid Plasty components are the central structural column and its base that hold up the computer and the tracking camera on the Sesamoid Plasty workstation. They are also designed to be disassembled such that the column can be folded onto itself for ease of transport after use. This is a retrospective recall report for a removal initiated on 17 June 2008
FDA Enforcement
Class II
·Terminated·Orthosoft, Inc. dba Zimmer CAS·June 14, 2017
NDI P7 Position Sensor, Stereotaxic Instrument
FDA Enforcement
Class II
·Terminated·Orthosoft, Inc. dba Zimmer CAS·May 17, 2017