Maestro Air Motor Pneumatic cranial drill motor. The Maestro Air Pneumatic System is a pneumatically operated surgical i

FDA device recall Z-1939-2016 · posted 2016-06-09 · Terminated

Recall details

Recalling firm

Stryker Instruments Div. of Stryker Corporation

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.

Action taken

Stryker sent an "Urgent Medical Device Recall Notification" dated April 28, 2016, to all affected customers. The recall notification included a description of the reason for the recall, affected product, customer responsibilities, and instructions for responding to the formal recall notification. For questions regarding this recall, please contact Stryker Instruments at (269) 389-4518.

Root cause

Component design/selection

Status

Terminated

Product code

HBB

Quantity affected

189

Distribution

Domestic only: AL AR CA FL GA IL IN KS KY MD MI MO NC NM OH OK SC TN TX VA WA WI

Date initiated

2016-04-28

Date posted

2016-06-09

Date terminated

2017-03-24

Location

Portage, MI

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