Recall Z-0177-2018 ยท OLO Orthopedic Stereotaxic Instrument
Zimmer Biomet, Inc.
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 ma
| Date | Oct 29, 2015 |
| Status | Terminated |
| 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. |
| Root cause | Software design |
| Action | Zimmer Biomet issued a retrospective report of a correction taken on 29-Oct-2015. The software issue described was corrected in the new software version 1.0.2.16. There were 2 copies of the affected software in distribution. Field Service Technicians were deployed to the consignee locations to perform the system upgrade. 100% of affected devices were updated with the software solution. No further action is required. |
| Quantity | 2 |
| Distribution | Worldwide Distribution including France and Germany |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151511 | ROSA Spine Medtech S.A, Jan 4, 2016 |