Z-3117-2017 Class II Terminated
FDA device recall Z-3117-2017 was initiated by Zimmer Biomet, Inc. on Jan 20, 2016 and is designated Class II. Reason for recall: Complaints were received reporting the system would freeze/shut down while in Fulgurate mode. The recall status is terminated (terminated Apr 30, 2018). Affected quantity: 64 devices.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 20, 2017
- Initiation Date
- Jan 20, 2016
- Termination Date
- Apr 30, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 64 devices
Product Description
Herga foot switch, model 6289-WS, a component of the ROSA Robotized Stereotactic Assistant Surgical Device, Model 2.5.8. The firm name on the foot switch label is Herga Electric Limited, Bury, St. Edmunds, Suffolk IP32 6NN. ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with three-dimensional imaging software and uses fiducial markers or optical registration. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments. It is indicated for any neurosurgical condition in which the use of stereotactic surgery may be appropriate
Reason for Recall
Complaints were received reporting the system would freeze/shut down while in Fulgurate mode.
Distribution Pattern
Worldwide Distribution - US (nationwide) and Internationally to Canada, China, France, Germany, India, Israel, Italy, Russia, Saudi Arabia, Spain and the United Kingdom.
Code Information
Serial numbers for ROSA devices with the Herga Footswitch in US distribution: Serial No. RO10009, RO10011, RO10014, RO13023, RO13027, RO14033, RO14035, RO14037, RO14038, RO14039, RO14040, RO14041, RO14043, RO15044, RO15045, RO15046, RO15048, RO15050, RO15051, RO15052, RO15053, RO15054, RO15058, RO15059, RO15060, RO15061, RO15062, RO15063, RO15064, RO15067, RO15069, and RO14031. Serial numbers for ROSA devices with the Herga Footswitch in foreign distribution: Serial No. RO08003, RO09004, RO09005, RO10007, RO10010, RO10013, RO11015, RO11016, RO11017, RO12018, RO12019, RO12020, RO12021, RO12022, RO13024, RO13025, RO13026, RO14029, RO14030, RO14032, RO14034, RO14036, RO14042, RO15047, RO15049, RO15055, RO15056, RO15057, RO15065, RO15066, RO15068, and RO15070.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-3117-2017
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026