Recall Z-2048-2017 ยท HAW Neurological Stereotaxic Instrument
Orthosoft, Inc. dba Zimmer CAS
NDI P7 Position Sensor, Stereotaxic Instrument
| Date | May 8, 2017 (initiated Jun 9, 2009) |
| Status | Terminated |
| Reason | Zimmer CAS voluntarily conducted a retrospective recall on specific P7 Position Sensors (Cameras), installed on Sesamoid and Sesamoid Plasty CAS workstations due to a series of these components determined to be affected with a manufacturing issue whereby they may potentially stop functioning during usage. |
| Root cause | Nonconforming Material/Component |
| Action | Zimmer CAS sent an Field Recall Notice dated June 9, 2009. Zimmer CAS conducted a retrospective recall/Field Correction on given P7 Position Sensors (Cameras). These were installed on given Sesamoid and Sesamoid Plasty CAS workstations. A series of these components have been determined to be affected with a manufacturing issue whereby they may potentially stop functioning during usage. The failure mode consists in the camera stopping to track and interrupting the application with an error code 0X00000020 being displayed on the navigation panel. For any questions or concerns please contact the |
| Quantity | 34 |
| Distribution | Worldwide Distribution - US Distribution to the states of : KS, MS, WI, NJ, KS, IN, LA, FL and WA., and to the countries of : Canada, Australia, Singapore, Netherlands, UK, Austria, Germany, Switzerland and Czech Republic. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071929 | NAVITRACK SYSTEM- PARTIAL HIP RESURFACING UNIVERSAL Orthosoft, Inc., Sep 19, 2007 |