Navitrack System - OS Knee Universal, Orthopedic Stereotaxic Instrument CAS Software application...
FDA Recall #Z-1881-2017 — Class II — October 6, 2011
Product Description
Navitrack System - OS Knee Universal, Orthopedic Stereotaxic Instrument CAS Software application intended to assist in the placement of total knee replacement components
Reason for Recall
Zimmer CAS voluntarily conducted a retrospective recall of the Navitrack System - OS Knee Universal software ORTHOsoft-UniTkr-2.3.2.6, due to a calibration sequence crash.
Recalling Firm
Orthosoft, Inc. dba Zimmer CAS — Montreal, N/A
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
105
Distribution
Worldwide Distribution - US including AZ CA CO FL GA IL IN KS MD MI MN MS OH OR PA SC SD TX VA WA and WI Internationally to Canada, Australia Austria Colombia Denmark France Germany Korea New Zealand Russia South Africa and Thailand
Code Information
Part Name: OS Knee Universal Part Number: ORTHOsoft-UniTkr-2 Affected Lot: ORTHOsoft-UniTkr-2.3.2.6
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated