Navitrack System - OS Knee Universal, Orthopedic Stereotaxic Instrument CAS Software application intended to assist in the placement of total knee replacement components
This recall has been terminated (originally issued April 26, 2017).
- Company
- Orthosoft, Inc. Dba Zimmer Cas
- Recall Initiated
- October 6, 2011
- Posted
- April 26, 2017
- Terminated
- May 8, 2017
- Recall Number
- Z-1881-2017
- Quantity
- 105
- Official Source
- View on FDA website ↗
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.
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
Lot / Code Info
Part Name: OS Knee Universal Part Number: ORTHOsoft-UniTkr-2 Affected Lot: ORTHOsoft-UniTkr-2.3.2.6
Root Cause
Software design
Action Taken
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.