Mako Surgical Recalls RIO Standard System Components for Connection Errors
Mako Surgical Corporation is recalling 910 units of the Makoplasty RIO Standard System and Ethernet to Fiber Optic Converter due to communication-connection errors.
What this means for you
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 classified as FDA Class II, and the source text does not report any injuries, illnesses, or deaths. The hazard is a communication-connection error, which is a functional defect but does not explicitly indicate a high risk of serious harm without further context.
Plain-English summary
Mako Surgical Corporation is recalling the Makoplasty RIO Standard System and the Ethernet to Fiber Optic Converter (Catalog # 200933). The recall involves 736 units distributed in the United States and 174 units distributed outside the United States. The affected products are used in the Partial Knee Application (PKA) for the Mako System, which is indicated for surgical knee procedures where stereotactic surgery may be appropriate.
The reason for the recall is a communication-connection error. The source text does not specify the exact nature of the error, the number of affected units, or any reported injuries or illnesses associated with the defect.
The recall covers all lots of the affected products. Distribution was worldwide, including the United States and various countries in Europe, Asia, and other regions. Consumers and healthcare providers should contact Mako Surgical Corporation for further instructions on how to handle the recalled devices.
The recalled product
- Product
- Makoplasty RIO Standard System; Ethernet to Fiber Optic Converter Catalog # 200933 Product Usage: The Partial Knee Application (PKA), for use with the Mako System, is indicated for use in surgical knee procedures, in which the use of stereotactic surgery may be appropriate, a
- Manufacturer
- Mako Surgical Corporation
- Hazard
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)
- ALL LOTS
Distribution
Distributed nationwide across the United States.
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