Zimmer Biomet, Inc. recalls MEDTECH ROSA Spine 1.0.2 The device is intended for the spatial positioning and orientation of instrument holders or to…

Recall date

February 27, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1755-2017

FDA classification

Class II

Brand / firm

Zimmer Biomet, Inc.

Sold / distributed

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

Why it was recalled

Unapproved change made by the supplier.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.