Z-0096-2018 Class II Terminated
FDA device recall Z-0096-2018 was initiated by Zimmer Biomet, Inc. on Dec 18, 2013 and is designated Class II. Reason for recall: Possible break in the connector of the Force Sensor. The recall status is terminated (terminated Jun 29, 2020). Affected quantity: 21 units total.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 22, 2017
- Initiation Date
- Dec 18, 2013
- Termination Date
- Jun 29, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 21 units total
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
Possible break in the connector of the Force Sensor.
Distribution Pattern
Nationwide Distribution to OH, MI, and TX
Code Information
Model Number: ROSA 2.5.8
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0096-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026