Medical device recalls Moderate risk

Stryker Instruments Div. of Stryker Corporation recalls Maestro Air Motor Pneumatic cranial drill motor. The Maestro Air Pneumatic System is a pneumatically operated surgical…

Recall date
April 28, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1939-2016
FDA classification
Class II
Brand / firm
Stryker Instruments Div. of Stryker Corporation
Sold / distributed
Domestic only: AL AR CA FL GA IL IN KS KY MD MI MO NC NM OH OK SC TN TX VA WA WI

Why it was recalled

Due to the buildup of grease within the hose and motor, the product may require multiple attempts to start. 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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