Z-0105-2018 Class II Terminated
FDA device recall Z-0105-2018 was initiated by Zimmer Biomet, Inc. on May 27, 2016 and is designated Class II. Reason for recall: Insufficient amount of washers in the Telescopic Arm, allowing some movement of the device. The recall status is terminated (terminated Jun 16, 2020). Affected quantity: 3 units.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 29, 2017
- Initiation Date
- May 27, 2016
- Termination Date
- Jun 16, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3 units
Product Description
ROSA Brain 3.0 Intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments. The device is indicated for any neurosurgical procedure in which the use of stereotactic surgery may be inappropriate.
Reason for Recall
Insufficient amount of washers in the Telescopic Arm, allowing some movement of the device.
Distribution Pattern
Worldwide Distribution - US (DC) and Internationally to Australia and France.
Code Information
Serial No. BR16004, BR15002, and BR15003
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0105-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026