Z-0100-2018 Class II Terminated
FDA device recall Z-0100-2018 was initiated by Zimmer Biomet, Inc. on Apr 19, 2012 and is designated Class II. Reason for recall: Potential failure of the optical distance sensor due to cable disconnection. The recall status is terminated (terminated Jun 16, 2020). Affected quantity: 14 units.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 22, 2017
- Initiation Date
- Apr 19, 2012
- Termination Date
- Jun 16, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14 units
Product Description
ROSA Surgical Device 2.5.8 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
Potential failure of the optical distance sensor due to cable disconnection.
Distribution Pattern
Worldwide Distribution - US including OH and MI Internationally to Canada, China, France, Germany, and Italy
Code Information
Serial No. RO10011 and RO10014
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0100-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026