Navitrack¿ System - OS Knee Universal, Orthopedic Stereotaxic Instrument
FDA Recall #Z-2075-2017 — Class III — June 20, 2008
Product Description
Navitrack¿ System - OS Knee Universal, Orthopedic Stereotaxic Instrument
Reason for Recall
ZIMMER CAS voluntarily conducted a retrospective recall of the Navitrack System - OS Knee Universal, due to software anomalies which were corrected with a new revision in version 2.2.1.3.
Recalling Firm
Orthosoft, Inc. dba Zimmer CAS — Montreal
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Devices
Product Quantity
152
Distribution
Domestic: CA, FL, GA, IL, IN, KS, MD, MN, MS, NC, NJ, NY, OR, PA, RI, SD, TN, TX, WA, WI Foreign: Germany, Spain, Czech Republic, Netherlands, Switzerland, New Zealand, Morocco, Brazil, Australia, Austria, France, Italy, Singapore, United Kingdom
Code Information
Product Name: Orthosoft Universal TKR (software application) Product Number: ORTHOsoft-UniTkr-2 Affected Lot #: Software release version ORTHOsoft-UniTkr-2.2.0.82
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated