55 results
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10ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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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
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, 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
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
SmartTools Knee System Orthopedic Stereotaxic Instrument
FDA Enforcement
Class II
·Terminated·Orthosoft, Inc. dba Zimmer CAS·April 26, 2017
NavitrackER Kit A: Knee, Model Number 20-8000-000-07,
FDA Enforcement
Class II
·Ongoing·Orthosoft, Inc. dba Zimmer CAS·March 9, 2022
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
HGP II ACETABULAR CUP MOD
FDA Enforcement
Class II
·Terminated·Zimmer, Inc.·February 26, 2014
ASIA ONE-PIECE LAG SCREW
FDA Enforcement
Class II
·Terminated·Zimmer, Inc.·February 26, 2014
FEM HD ION (various sizes)
FDA Enforcement
Class II
·Terminated·Zimmer, Inc.·February 26, 2014
CPT DEGREE TAPER (various sizes) and FEMORAL HD (various sizes)
FDA Enforcement
Class II
·Terminated·Zimmer, Inc.·February 26, 2014
3.5 COMP PLT, 4 HOLE 3.5 COMP PLT, 5 HOLE 3.5 COMP PLT, 6 HOLE 3.5 COMP PLT, 8 HOLE 3.5 COMP PLT, 9 HOLE 3.5 COMP PLT, 10 HOLE
FDA Enforcement
Class II
·Terminated·Zimmer, Inc.·February 26, 2014
Nextgen Complete Knee Solution Femoral and Provisional Impactor/ Extractor, REF 00-5901-026-00, Non-Sterile Zimmer, Warsaw Indiana The instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components.
FDA Enforcement
Class II
·Terminated·Zimmer Inc.·August 8, 2012
Nextgen Complete Knee Solution Replacement Jaw for Use with Femoral and Provisional Impactor/Extractor, REF 00-5901-026-40, Non-Sterile Zimmer, Warsaw Indiana The instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components.
FDA Enforcement
Class II
·Terminated·Zimmer Inc.·August 8, 2012
VERSYS HERITAGE FEM STEM
FDA Enforcement
Class II
·Terminated·Zimmer, Inc.·February 26, 2014
Moore Hip Prosthesis Long Fenestrated Stem 38 mm (1-1/2 Inch) Head Diameter 203 mm Length. Product Usage: The Moore Hip Prosthesis is a femoral him stem that can be used where there is roentgenogrpahic evidence of a satisfactory actabulum and sufficient bone in the femoral neck to seat the prosthesis with or without bone cement.
FDA Enforcement
Class II
·Terminated·Zimmer, Inc.·August 20, 2014
MODULAR AUSTIN MOORE FENE. Item codes starting with 45502001, 455503001 and 455504001
FDA Enforcement
Class II
·Terminated·Zimmer, Inc.·February 26, 2014