FDA Device recall Z-0177-2018
Rosa Spine 1.0.2 Stereotaxic Instrument Computer-Assisted Surgical Device The device is intended for the spatial positioning and orientatio…
- FDA Device
- Class II
- terminated
- Published 2017-12-06
On 2017-12-06 the FDA classified a Class II recall of Rosa Spine 1.0.2 Stereotaxic Instrument Computer-Assisted Surgical Device The device is intended for the spatial positioning and orientatio… by Zimmer Biomet, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0177-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-10-29 |
| Published | 2017-12-06 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Zimmer Biomet |
| Distribution | n/a |
Product
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
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.
Identifiers
| code_info | Serial #'s; SP14003 and SP14005 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0177-2018%22
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