Home / Recalls / Orthosoft, Inc. dba Zimmer CAS / Z-1881-2017

Z-1881-2017 Class II Terminated

Recalled by Orthosoft, Inc. dba Zimmer CAS — Montreal, N/A

Recall Details

Product Type
Devices
Report Date
May 3, 2017
Initiation Date
October 6, 2011
Termination Date
May 8, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
105

Product Description

Navitrack System - OS Knee Universal, Orthopedic Stereotaxic Instrument CAS Software application intended to assist in the placement of total knee replacement components

Reason for Recall

Zimmer CAS voluntarily conducted a retrospective recall of the Navitrack System - OS Knee Universal software ORTHOsoft-UniTkr-2.3.2.6, due to a calibration sequence crash.

Distribution Pattern

Worldwide Distribution - US including AZ CA CO FL GA IL IN KS MD MI MN MS OH OR PA SC SD TX VA WA and WI Internationally to Canada, Australia Austria Colombia Denmark France Germany Korea New Zealand Russia South Africa and Thailand

Code Information

Part Name: OS Knee Universal Part Number: ORTHOsoft-UniTkr-2 Affected Lot: ORTHOsoft-UniTkr-2.3.2.6

Other recalls by Orthosoft, Inc. dba Zimmer CAS

  • Z-0721-2022 Class II — NavitrackER Kit A: Knee, Model Number 20-8000-000-07, (January 7, 2022)
  • Z-1868-2017 Class II — SmartTools Knee System Orthopedic Stereotaxic Instrument (February 20, 2017)
  • Z-2048-2017 Class II — NDI P7 Position Sensor, Stereotaxic Instrument (June 9, 2009)
  • Z-2076-2017 Class II — Navitrack System - OS Knee Universal, Stereotaxic instrument (October 28, 2008)
  • Z-2075-2017 Class III — Navitrack¿ System - OS Knee Universal, Orthopedic Stereotaxic Instrument (June 20, 2008)
  • Z-2227-2017 Class II — Sesamoid Plasty, Stereotaxic Instrument The Sesamoid Plasty workstation is used (June 4, 2008)