Zimmer Biomet, Inc.: Medical Device Recall in 2017 - (Recall #: Z-1755-2017)

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:

MEDTECH ROSA Spine 1.0.2 The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons 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 lumbar vertebrae with a posterior approach.

Product Classification:

Class II

Date Initiated: February 27, 2017

Date Posted: April 19, 2017

Recall Number: Z-1755-2017

Event ID: 76820

Reason for Recall:

Unapproved change made by the supplier.

Status: Terminated

Product Quantity: 1

Code Information:

Serial #'s: SP16008

Distribution Pattern:

Nationwide Distribution to CA, FL, IL, KY, MA, MN, NC, NY, OH, PA, and District of Columbia.

Voluntary or Mandated:

Voluntary: Firm initiated