191 results
·
27ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
×
Zimmer/CAS Power Cord, Sesamoid Plasty, NA, Zimmer/CAS, Montreal (Quebec), Canada; REF 20-8000-070-12. The device is the power cord component for the Sesamoid Plasty CAS workstation which connects the workstation to the power mains.
FDA Recall
Terminated
·Zimmer Inc.·Product code HAW·November 2, 2009
NDI P7 Position Sensor, Stereotaxic Instrument
FDA Recall
Terminated
·Orthosoft, Inc. dba Zimmer CAS·Product code HAW·June 9, 2009
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
Tibial Alignment Guide; Orthopedic Stereotaxic Instrument;
FDA Recall
Terminated
·Zimmer CAS·Product code OLO·April 19, 2015
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 Enforcement
Class II
·Terminated·Orthosoft, Inc. dba Zimmer CAS·May 17, 2017
Tibial Alignment Guide; Orthopedic Stereotaxic Instrument;
FDA Enforcement
Class II
·Terminated·Zimmer CAS·June 10, 2015
Navitrack¿ System - OS Knee Universal, Orthopedic Stereotaxic Instrument
FDA Enforcement
Class III
·Terminated·Orthosoft, Inc. dba Zimmer CAS·May 24, 2017
Navitrack System - OS Knee Universal, Stereotaxic instrument
FDA Enforcement
Class II
·Terminated·Orthosoft, Inc. dba Zimmer CAS·May 24, 2017
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 Enforcement
Class II
·Terminated·Orthosoft, Inc. dba Zimmer CAS·June 14, 2017
PSI Knee System- Prosthesis, knee patellofemorotibial, semi-constrained, cemented, polymer/meal/polymer The Zimmer PSI Knee System is indicated as an orthopedic instrument system to assist in the positioning of knee replacement components.
FDA Recall
Terminated
·Zimmer CAS·Product code JWH·November 3, 2014
PSI Knee System- Prosthesis, knee patellofemorotibial, semi-constrained, cemented, polymer/meal/polymer The Zimmer PSI Knee System is indicated as an orthopedic instrument system to assist in the positioning of knee replacement components.
FDA Enforcement
Class II
·Terminated·Zimmer CAS·December 10, 2014
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
FDA Recall
Terminated
·Orthosoft, Inc. dba Zimmer CAS·Product code HAW·June 20, 2008
SmartTools Knee System Orthopedic Stereotaxic Instrument
FDA Recall
Terminated
·Orthosoft, Inc. dba Zimmer CAS·Product code OLO·February 20, 2017
SmartTools Knee System Orthopedic Stereotaxic Instrument
FDA Enforcement
Class II
·Terminated·Orthosoft, Inc. dba Zimmer CAS·April 26, 2017
Zimmer PERSONA Distal Valgus Alignment Guide, Nonsterile. orthopedic surgical instrument. The device sets the proper Varus/Valgus alignment of a patient's knee prior to the initial femoral resection cut being made.
FDA Recall
Terminated
·Zimmer, Inc.·Product code LXH·July 30, 2014
PRESSFIT FEM ST FX 16 X 1
FDA Enforcement
Class II
·Terminated·Zimmer, Inc.·February 26, 2014
ZIMTRON 6 DEG 22 HEADS
FDA Enforcement
Class II
·Terminated·Zimmer, Inc.·February 26, 2014