Reported Dec 6, 2017 · Terminated
Rosa Spine 1.0.2 Stereotaxic Instrument Computer-Assisted Surgical Device The device is intended for the spatial…
Zimmer Biomet, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Zimmer Biomet, Inc. · 1800 W Center St · Warsaw, IN · 46580-2304
Is this the product you have?
- 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.
- Lot codes and dates
- Serial #'s; SP14003 and SP14005
- Amount recalled
- 2
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
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.
This product could cause temporary or reversible health problems — stop using it.
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