Z-0177-2018 Class II Terminated
FDA device recall Z-0177-2018 was initiated by Zimmer Biomet, Inc. on Oct 29, 2015 and is designated Class II. Reason for recall: A design change was initiated to update ROSA Spine 1.0.2 to version ROSA Spine 1.0.2.16 to resolve software bugs and improve usability and stability of the ROSA Spine device. The recall status is terminated (terminated Jun 16, 2020). Affected quantity: 2.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 6, 2017
- Initiation Date
- Oct 29, 2015
- Termination Date
- Jun 16, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2
Product Description
Rosa Spine 1.0.2 Stereotaxic Instrument Computer-Assisted Surgical Device The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by surgeons to guide standard neurosurgical instruments during spine surgery. Guidance is based on an intra-operative plan developed with three-dimensional imaging software provided that the required fiducial markers and rigid patient anatomy can be identified on 3D CT scans. The device is indicated for the placement of pedicle screws in lumber vertebrae with a posterior approach.
Reason for Recall
A design change was initiated to update ROSA Spine 1.0.2 to version ROSA Spine 1.0.2.16 to resolve software bugs and improve usability and stability of the ROSA Spine device.
Distribution Pattern
Worldwide Distribution including France and Germany
Code Information
Serial #'s; SP14003 and SP14005
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0177-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026