—#159599

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.

FDA product code: OLO — Orthopedic Stereotaxic Instrument
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K151511
Affected lot / code info: Serial #'s; SP14003 and SP14005

Why it was recalled

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 (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Zimmer Biomet, Inc.
Address: 1800 W Center St, Warsaw, Indiana 46580-2304

Distribution

Distribution pattern: Worldwide Distribution including France and Germany

Timeline

Recall initiated: 2015-10-29
Terminated: 2020-06-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #159599. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.