The Recall Desk
ModerateFDA (Devices)·Z-1939-2016·Announced 2016-06-15

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.

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 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.
Affected units
189

Distribution

Same manufacturer · Stryker Instruments Div. of Stryker Corporation

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