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Recall Observatory FDA recall evidence

Device product

Navitrack¿ System - OS Knee Universal, Orthopedic Stereotaxic Instrument

Z-2075-2017

June 20, 2008

Class III

Product summary

Firm
Orthosoft, Inc. dba Zimmer CAS
Event
Event 75612
Status
Terminated
Classification
Class III
Quantity
152
Official record key
device-enforcement:Z-2075-2017

Official wording

Reason: 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.

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

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

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software anomalies