Home / Recalls / Medical Devices
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
Recalled April 19, 2017 · FDA recall Z-1755-2017 · Zimmer Biomet
Hazard
Unapproved change made by the supplier. · FDA Class II
Units
1
Sold at
Nationwide Distribution to CA, FL, IL, KY, MA, MN, NC, NY, OH, PA, and District of Columbia.
Description
Unapproved change made by the supplier.
Product
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.
Manufacturer(s)
Zimmer Biomet, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →