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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 orientat
Recalled November 22, 2017 · FDA recall Z-0102-2018 · Zimmer Biomet
Hazard
An undetected shift between the information displayed in the navigation software and the actual patient anatomy · FDA Class II
Units
21 (4 US and 17 OUS)
Sold at
OH, MI and TX
Description
An undetected shift between the information displayed in the navigation software and the actual patient anatomy
Product
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
Manufacturer(s)
Zimmer Biomet, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →