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Recall Observatory FDA recall evidence

Device product

Navitrack System - OS Knee Universal, Stereotaxic instrument

Z-2076-2017

October 28, 2008

Class II

Product summary

Firm
Orthosoft, Inc. dba Zimmer CAS
Event
Event 75613
Status
Terminated
Classification
Class II
Quantity
153
Official record key
device-enforcement:Z-2076-2017

Official wording

Reason: Zimmer CAS voluntarily conducted a retrospective recall of the Navitrack System OS Knee Universal software versions 2.2.0.82, 2.2.1.3, 2.1.6.0.2, D.54 and A.42 due to software issues resulting in erros and discrepancies .

Code information: Part Number, Lot Number/Serial Number ORTHOsoft-UniTkr- 2.2.0.82, 2.2.1.3 ORTHOsoft-UniTkr- 2.1.6.0.2 OsUniTkr (previous naming convention for ORTHOsoft-UniTkr)- D.54, A.42

Distribution pattern: Domestic: CA, FL, GA, IL, IN, KS, NC, NY, OH, OR, PA, RI, TN, TX, VA, WA Foreign: Canada, Australia Austria Brazil China Czech Republic France Germany Israel Italy Lebanon Luxembourg Netherlands New Zealand Spain Sweden Switzerland United Kingdom

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Zimmer CAS voluntarily conducted a retrospective recall of the Navitrack System OS Knee Universal software versions 2.2.0.82, 2.2.1.3, 2.1.6.0.2, D.54 and A.42 due to software issues resulting in erros and discrepancies .