Recall Z-1939-2016— Stryker Instruments Div. of Stryker Corporation

Name: FDA recall Z-1939-2016
Creator: U.S. Food and Drug Administration
Published: 2016-04-28

Class II · Terminated

Class II FDA medical device recall by Stryker Instruments Div. of Stryker Corporation, initiated 2016-04-28, terminated 2017-03-24. It names one FDA 510(k) clearance: K150801. 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.. Reason: 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..

Recalling firm: Stryker Instruments Div. of Stryker Corporation
Classification: Class II
Status: Terminated
Initiated: 2016-04-28
Terminated: 2017-03-24
Firm location: Portage, MI, United States

510(k) clearances named in this recall

1 on FDA's record

K150801 — Stryker Maestro Air MotorsStryker Corporation·cleared 2015-05-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.