Z-0099-2018 Class II Terminated
FDA device recall Z-0099-2018 was initiated by Zimmer Biomet, Inc. on Feb 5, 2013 and is designated Class II. Reason for recall: Observed instability of the device. The recall status is terminated (terminated Jul 22, 2020). Affected quantity: 53 units.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 22, 2017
- Initiation Date
- Feb 5, 2013
- Termination Date
- Jul 22, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 53 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
Observed instability of the device.
Distribution Pattern
Nationwide Distribution to AL, AR, CA, CO, CT, FL, GA, KY, MA, MI, NY, OH, PA, and TX
Code Information
Serial No. RO10009, RO10011, RO10014, RO13023, RO13027, RO14031, RO14033, RO14035, RO14037, RO14038, RO14039, RO14040, RO14041, RO14043, RO15044, RO15045, RO15046, RO15048, RO15050, RO15051, RO15058, RO15059, RO15061, RO15063, RO15064, and RO15069
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0099-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026