Mako Surgical Recalls Robotic Arm Interactive Orthopedic System for Manual Revision
Mako Surgical Corporation is recalling 249 Robotic Arm Interactive Orthopedic System (RIO) units worldwide to revise the field manual.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is for a documentation issue (field manual revision) with no reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
Mako Surgical Corporation is recalling 249 units of the Robotic Arm Interactive Orthopedic System (RIO) to revise the field manual. The recall affects catalog numbers 203900 and 207092 across all lots.
The affected devices were distributed nationwide and internationally to Australia, Italy, Japan, Hong Kong, Scotland, Germany, Turkey, Greece, Singapore, Taiwan, and South Korea. The recall is classified as Class II by the FDA.
Healthcare providers should contact Mako Surgical Corporation for instructions on revising the field manual for the recalled devices.
The recalled product
- Product
- Robotic Arm Interactive Orthopedic System (RIO)
- Manufacturer
- Mako Surgical Corporation
- Hazard
- Affected units
- 249
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 (1)
- Catalog # 203900 & 207092 All lots
Distribution
Distributed nationwide across the United States.
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