Home / Recalls / Orthosoft, Inc. dba Zimmer CAS / Z-2075-2017

Z-2075-2017 Class III Terminated

Recalled by Orthosoft, Inc. dba Zimmer CAS — Montreal

Recall Details

Product Type
Devices
Report Date
May 24, 2017
Initiation Date
June 20, 2008
Termination Date
May 15, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
152

Product Description

Navitrack¿ System - OS Knee Universal, Orthopedic Stereotaxic Instrument

Reason for Recall

ZIMMER CAS voluntarily conducted a retrospective recall of the Navitrack System - OS Knee Universal, due to software anomalies which were corrected with a new revision in version 2.2.1.3.

Distribution Pattern

Domestic: CA, FL, GA, IL, IN, KS, MD, MN, MS, NC, NJ, NY, OR, PA, RI, SD, TN, TX, WA, WI Foreign: Germany, Spain, Czech Republic, Netherlands, Switzerland, New Zealand, Morocco, Brazil, Australia, Austria, France, Italy, Singapore, United Kingdom

Code Information

Product Name: Orthosoft Universal TKR (software application) Product Number: ORTHOsoft-UniTkr-2 Affected Lot #: Software release version ORTHOsoft-UniTkr-2.2.0.82

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-1881-2017 Class II — Navitrack System - OS Knee Universal, Orthopedic Stereotaxic Instrument CAS Sof (October 6, 2011)
  • 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-2227-2017 Class II — Sesamoid Plasty, Stereotaxic Instrument The Sesamoid Plasty workstation is used (June 4, 2008)