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Recall Observatory FDA recall evidence

Device product

Navitrack System - OS Knee Universal, Orthopedic Stereotaxic Instrument CAS Software application intended to assist in the placement of total knee replacement components

Z-1881-2017

October 06, 2011

Class II

Product summary

Firm
Orthosoft, Inc. dba Zimmer CAS
Event
Event 75614
Status
Terminated
Classification
Class II
Quantity
105
Official record key
device-enforcement:Z-1881-2017

Official wording

Reason: 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.

Code information: Part Name: OS Knee Universal Part Number: ORTHOsoft-UniTkr-2 Affected Lot: ORTHOsoft-UniTkr-2.3.2.6

Distribution pattern: 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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.