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.
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: 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
- Affected units
- 2
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
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