Recall Z-1881-2017 ยท OLO Orthopedic Stereotaxic Instrument
Orthosoft, Inc. dba Zimmer CAS
Navitrack System - OS Knee Universal, Orthopedic Stereotaxic Instrument CAS Software application intended to assist in the placement of total knee replacement components
| Date | Apr 26, 2017 (initiated Oct 6, 2011) |
| Status | Terminated |
| 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. |
| 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: cassupport@zimmercas.com 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 | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110054 | NAVITRACK SYSTEM - OS KNEE UNIVERSAL, CAS SAME INCISION TIBIA REFERENCE Zimmer Cas, Mar 24, 2011 |