Stryker Recalls Maestro Air Motor Pneumatic Cranial Drill Units
Stryker is recalling 189 Maestro Air Motor pneumatic cranial drill units because grease buildup may cause the orange grease to leak and contaminate surgical wounds.
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 source text explicitly describes the risk of contamination as having a 'negligible possibility' and notes that the agency classification is Class II, which aligns with the rubric for moderate severity involving low-risk contamination or theoretical hazards without reported injuries.
Plain-English summary
Stryker Instruments Div. of Stryker Corporation is recalling 189 units of the Maestro Air Motor, a pneumatic cranial drill motor used in the Maestro Air Pneumatic System. The system is a pneumatically operated surgical instrument where the motor provides power to operate removable rotating surgical cutting tools and their accessories.
The recall is due to the buildup of grease within the hose and motor, which may require multiple attempts to start the device. The grease may also migrate into the attachment end of the motor. There is a negligible possibility that the orange grease may leak from the attachment end of the motor and contaminate the surgical wound, resulting in soft tissue inflammation.
The affected units were distributed domestically to facilities in Alabama, Arkansas, California, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Maryland, Michigan, Missouri, North Carolina, New Mexico, Ohio, Oklahoma, South Carolina, Tennessee, Texas, Virginia, Washington, and Wisconsin. The specific model number is 5407-200-000. Users should check their serial numbers against the list provided in the official recall notice to determine if their unit is affected.
The recalled product
- Product
- Maestro Air Motor Pneumatic cranial drill motor. The Maestro Air Pneumatic System is a pneumatically operated surgical instrument system. The pneumatic motor provides power to operate removable rotating surgical cutting tools and their accessories.
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
- Affected units
- 189
Distribution
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