FDAFDA · Food and drugs·Recall number Z-2076-2017
Navitrack System - OS Knee Universal, Stereotaxic instrument
Published May 24, 2017 · Recall initiated: October 28, 2008
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 .
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Orthosoft, Inc. dba Zimmer CAS
- Distributor
- 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
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Canada
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