Z-1881-2017Class II

Navitrack System - OS Knee Universal, Orthopedic Stereotaxic Instrument CAS Software application intended to...

Name: Z-1881-2017 Navitrack System - OS Knee Universal, Orthopedic Stereotaxic Instrument CAS Software application intended to...
Creator: Orthosoft, Inc. dba Zimmer CAS
Published: 2011-10-06
License: https://open.fda.gov/license/

Zimmer CAS / initiated 2011-10-06 / Terminated / root cause: software

FDA source

Orthosoft, Inc. dba Zimmer CAS began a recall of Navitrack System - OS Knee Universal, Orthopedic Stereotaxic Instrument CAS Software application intended to assist in the placement of total knee replacement... on 2011-10-06. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1881-2017
Classification: Class II
Status: Terminated
Initiated: 2011-10-06
Posted: 2017-04-26
Terminated: 2017-05-08
Recalling firm: Zimmer CAS
Product: Navitrack System - OS Knee Universal, Orthopedic Stereotaxic Instrument CAS Software application intended to assist in the placement of total knee replacement components
Product code: OLO Orthopedic Stereotaxic Instrument
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.
Root cause tag: software
FDA root cause: Software design
Action: Zimmer sent a Medical Device Field Notification letter dated December 6, 2011, to all affected customers. This is a retrospective report of a correction taken on 6 December 2011. The software issues were fixed in the new software version 2.3.3.0. Recall notices were distributed on December 6, 2011. Telephone: 18663367846 (US & Canada) or 5143958883 (International), Email: [email protected] Customers with questions should call 1-866-336-7846 (US & Canada) 514-395-8883 (International). For questions regarding this recall call 574-372-4487.
Quantity in commerce: 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
Product codes and lots: Part Name: OS Knee Universal Part Number: ORTHOsoft-UniTkr-2 Affected Lot: ORTHOsoft-UniTkr-2.3.2.6

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1881-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1881-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-03	2017-04-26

Product code OLO

K110054Class IINavitrack System - Os Knee Universal, Cas Same Incision Tibia ReferenceZimmer Cas / cleared 2011-03-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)