Zimmer Biomet, Inc. ROSA Surgical Device 2.5.8, a computer-controlled electromechanical arm to guide standard neurosurgical instruments. Recall
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ROSA Surgical Device 2.5.8, a computer-controlled electromechanical arm to guide standard neurosurgical instruments.
Brand
Zimmer Biomet, Inc.
Lot Codes / Batch Numbers
Model No. 2.5.8., Serial No. RO10009, RO10011, RO10014, RO13023, RO13027, RO14031, RO14033, RO14035, and RO14037.
Products Sold
Model No. 2.5.8., Serial No. RO10009, RO10011, RO10014, RO13023, RO13027, RO14031, RO14033, RO14035, and RO14037.
Zimmer Biomet, Inc. is recalling ROSA Surgical Device 2.5.8, a computer-controlled electromechanical arm to guide standard neurosurgi due to Potential failure of a force feedback sensor that may result in continued movement of an operating arm (rather than an immediate stop as intended).. This is a Class I recall, indicating a high risk of serious health consequences or death. Based on FDA medical device enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential failure of a force feedback sensor that may result in continued movement of an operating arm (rather than an immediate stop as intended).
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AR, GA, IN, MI, OH, TX
Page updated: Jan 13, 2026