Navitrack System - OS Knee Universal, Stereotaxic instrument
FDA Recall #Z-2076-2017 — Class II — October 28, 2008
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 .
Recalling Firm
Orthosoft, Inc. dba Zimmer CAS — Montreal
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
153
Distribution
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
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated