Z-2076-2017 Class II Terminated

Recalled by Orthosoft, Inc. dba Zimmer CAS — Montreal

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