Zimmer Biomet, Inc.: Medical Device Recall in 2017 - (Recall #: Z-0177-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: October 29, 2015

Date Posted: December 6, 2017

Recall Number: Z-0177-2018

Event ID: 78443

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.

Status: Terminated

Product Quantity: 2

Code Information:

Serial #'s; SP14003 and SP14005

Distribution Pattern:

Worldwide Distribution including France and Germany

Voluntary or Mandated:

Voluntary: Firm initiated