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Zimmer Biomet, Inc. recalls ROSA Surgical Device 2.5.8, a computer-controlled electromechanical arm to guide standard neurosurgical instruments.
Recalled November 29, 2017 · FDA recall Z-0160-2018 · Zimmer Biomet
Hazard
Potential failure of a force feedback sensor that may result in continued movement of an operating arm (rather than an immediate stop as intended). · FDA Class II
Units
31 units
Sold at
US distribution in AR, GA, OH, MI, and TX.
Description
Potential failure of a force feedback sensor that may result in continued movement of an operating arm (rather than an immediate stop as intended).
Product
ROSA Surgical Device 2.5.8, a computer-controlled electromechanical arm to guide standard neurosurgical instruments.
Manufacturer(s)
Zimmer Biomet, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →