Stryker USB Converter in Mako Robotic Surgery System May Fail
Mako Surgical Corporation is recalling certain Stryker USB Converter components that may arrive non-functional or fail during use. Affected units are in Illinois and Arizona.
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: This is an FDA Class II recall with no reported injuries or illnesses. The hazard is a potential device malfunction (non-functionality or error display) rather than a known safety defect, qualifying this as a precautionary recall.
Plain-English summary
The recalled product is the Stryker USB Converter (Catalog #201148), a component of the Mako Robotic-Arm Assisted Surgery System manufactured by Mako Surgical Corporation.
Certain units may arrive non-functional from the manufacturer, become non-functional during use, or display an error light while in operation.
The recall affects two units distributed in Illinois and Arizona. The affected lot number is #22041607 (UDI-DI: 07613327407280).
Customers who have received affected units should contact Mako Surgical Corporation or their Stryker representative regarding replacement or repair of the component.
The recalled product
- Product
- Stryker USB Converter, Polaris Spectra Camera, Catalog #201148, a component of the Mako Robotic-Arm Assisted Surgery System.
- Manufacturer
- Mako Surgical Corporation
- Hazard
- device-malfunction
- component-failure
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 (2)
- Lot #22041607
- UDI-DI (GTIN) 07613327407280.
Distribution
Distributed in 2 states:
- AZ
- IL
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