Navitrack System - OS Knee Universal, Orthopedic Stereotaxic Instrument CAS Software application intended to assist in the placement of total knee replacement components
FDA Recall Z-1881-2017 · Posted 2017-04-26
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Recalling FirmOrthosoft, Inc. dba Zimmer CAS
Recall StatusTerminated
Product CodeOLO
Date Initiated2011-10-06
Date Terminated2017-05-08
Product Quantity105
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.
Firm 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.
Root Cause
Software design
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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