Orthosoft, Inc. dba Zimmer CAS NDI P7 Position Sensor, Stereotaxic Instrument Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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.

Recommended Action

Per FDA guidance

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 Zimmer CAS customer service, 1-866-336-7846.

Distribution

As reported by FDA

FL, IN, KS, LA, MS, NJ, WA, WI