Z-0184-2018 Class II Terminated
FDA device recall Z-0184-2018 was initiated by Zimmer Biomet, Inc. on Sep 5, 2014 and is designated Class II. Reason for recall: The software issue described was corrected in the modification to the MXTTOUT controller parameter settings. The recall status is terminated (terminated Jun 9, 2020). Affected quantity: 29 (8 US and 21 OUS).
Recall Details
- Product Type
- Devices
- Report Date
- Dec 6, 2017
- Initiation Date
- Sep 5, 2014
- Termination Date
- Jun 9, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 29 (8 US and 21 OUS)
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
The software issue described was corrected in the modification to the MXTTOUT controller parameter settings.
Distribution Pattern
Nationwide Distribution to AK, OH, TX, GA, and MI
Code Information
Serial #'s: RO10009, RO10011, RO10014, RO13023, RO13027, RO14031, RO14033 and RO14035
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0184-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026