Zimmer Biomet, Inc. recalls ROSA Surgical Device 2.5.8. It is intended to be used in the operating room for the spatial positioning and orientation…
- Recall date
- February 14, 2014
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0102-2018
- FDA classification
- Class II
- Brand / firm
- Zimmer Biomet, Inc.
- Sold / distributed
- OH, MI and TX
Why it was recalled
An undetected shift between the information displayed in the navigation software and the actual patient anatomy
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 Surgical Device 2.5.8. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide
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