FDA Recalls Zimmer Biomet ROSA Surgical Devices Due to Sensor Failure
The FDA is recalling 31 Zimmer Biomet ROSA Surgical Devices because a force feedback sensor may fail, causing the operating arm to continue moving instead of stopping.
The agency’s classification
FDA (Devices): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, FDA Class II recalls involving significant injury or structural defects are rated as Severe (4). The potential for an operating arm to continue moving during surgery presents a significant risk of harm.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling 31 units of the Zimmer Biomet ROSA Surgical Device 2.5.8. This device is a computer-controlled electromechanical arm designed to guide standard neurosurgical instruments. The recall is classified as Class II by the FDA.
The recall is being issued due to a potential failure of a force feedback sensor. If this sensor fails, the operating arm may continue to move rather than stopping immediately as intended. This malfunction could occur during surgical procedures.
The affected units were distributed in the United States to locations in Arkansas, Georgia, Ohio, Michigan, and Texas. The specific serial numbers involved are RO10009, RO10011, RO10014, RO13023, RO13027, RO14031, RO14033, RO14035, and RO14037. Healthcare facilities and users should contact Zimmer Biomet, Inc. for instructions on how to return or replace the affected devices.
The recalled product
- Product
- ROSA Surgical Device 2.5.8, a computer-controlled electromechanical arm to guide standard neurosurgical instruments.
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 31
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- Model No. 2.5.8.
- Serial No. RO10009
- RO10011
- RO10014
- RO13023
- RO13027
- RO14031
- RO14033
- RO14035
- and RO14037.
Distribution
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