Recall Z-1939-2016 ยท HBB Motor, Drill, Pneumatic
Stryker Instruments Div. of Stryker Corporation
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.
| Date | Jun 9, 2016 (initiated Apr 28, 2016) |
| Status | Terminated |
| 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. |
| Root cause | Component design/selection |
| Action | 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. |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K150801 | Stryker Maestro Air Motors Stryker Corporation, May 22, 2015 |