NDI P7 Position Sensor, Stereotaxic Instrument
FDA Recall Z-2048-2017 · Posted 2017-05-08
Recalling FirmOrthosoft, Inc. dba Zimmer CAS
Recall StatusTerminated
Product CodeHAW
Date Initiated2009-06-09
Date Terminated2017-05-09
Product Quantity34
Reason for Recall
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.
Firm 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 Zimmer CAS customer service, 1-866-336-7846.
Root Cause
Nonconforming Material/Component
Distribution Pattern
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.
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.