Z-2076-2017 Class II Terminated
FDA device recall Z-2076-2017 was initiated by Orthosoft, Inc. dba Zimmer CAS on October 28, 2008 and is designated Class II. Reason for recall: 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 err… The recall status is terminated (terminated May 15, 2017). Affected quantity: 153.
Recall Details
- Product Type
- Devices
- Report Date
- May 24, 2017
- Initiation Date
- October 28, 2008
- Termination Date
- May 15, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 153
Product Description
Navitrack System - OS Knee Universal, Stereotaxic instrument
Reason for Recall
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 .
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
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