Zimmer Biomet, Inc. recalls ROSA Brain 3.0 Intended for the spatial positioning and orientation of instrument holders or tool guides to be used by…
- Recall date
- May 27, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0105-2018
- FDA classification
- Class II
- Brand / firm
- Zimmer Biomet, Inc.
- Sold / distributed
- Worldwide Distribution - US (DC) and Internationally to Australia and France.
Why it was recalled
Insufficient amount of washers in the Telescopic Arm, allowing some movement of the device.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
ROSA Brain 3.0 Intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments. The device is indicated for any neurosurgical procedure in which the use of stereotactic surgery may be inappropriate.
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