Maestro Air Motor Pneumatic cranial drill motor. The Maestro Air Pneumatic System is a pneumat...
FDA Device Recall #Z-1939-2016 — Class II — April 28, 2016
Recall Summary
| Recall Number | Z-1939-2016 |
| Classification | Class II — Moderate risk |
| Date Initiated | April 28, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Stryker Instruments Div. of Stryker Corporation |
| Location | Portage, MI |
| Product Type | Devices |
| Quantity | 189 |
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.
Distribution Pattern
Domestic only: AL AR CA FL GA IL IN KS KY MD MI MO NC NM OH OK SC TN TX VA WA WI
Lot / Code Information
Model Number: 5407-200-000 S/N: 1522406703 1522406713 1522406733 1522406743 1522406753 1522406763 1522406773 1522406793 1522406803 1522406813 1522406833 1522406843 1522406853 1522406863 1522406873 1522406883 1522406893 1522406903 1522406923 1523018583 1523018603 1523018623 1523018633 1523018683 1523018713 1523018723 1523018733 1523018743 1523018773 1523018783 1523018813 1523018823 1523018833 1523018843 1523018853 1523018863 1523018873 1523018883 1523018893 1523018903 1523018913 1523601703 1523601723 1523601733 1523601743 1523601763 1523601773 1523601783 1523601793 1523601813 1523601823 1523601833 1523601843 1523601863 1523601873 1523601883 1523601893 1523601903 1523601913 1523601923 1523601933 1523601943 1523904263 1523904273 1523904283 1523904293 1523904303 1523904313 1523904333 1523904343 1523904353 1523904363 1523904373 1523904383 1523904393 1523904403 1523904413 1523904423 1523904433 1523904443 1523904453 1523904463 1523904473 1523904493 1523904503 1523904513 1523904523 1523904543 1523906203 1523906213 1523906223 1523906233 1523906243 1523906253 1523906263 1523906273 1523906283 1526102833 1526102843 1526102853 1526102863 1526102873 1526102893 1526102903 1526102913 1526102923 1526102933 1526102943 1526102953 1526102963 1526102973 1526102983 1526102993 1526103003 1526103013 1526103023 1526103033 1526103043 1526103053 1526804843 1526804853 1526804863 1526804873 1526804883 1526804903 1526804933 1526804953 1526804993 1526805003 1526805013 1526805023 1526805033 1526902093 1526902103 1526902113 1526902133 1528503293 1528503303 1528503313 1528503323 1528503333 1528503393 1528503433 1528503453 1528503463 1528503473 1528503483 1528503583 1528503623 1528503633 1528503643 1528503653 1528503663 1528503683 1528503693 1528503713 1528503793 1528503803 1528503823 1528503833 1528503843 1528503853 1528503863 1528503873 1528503883 1535100493 1535100523 1535100553 1535100563 1535100573 1535100613 1535100623 1535100633 1535100653 1535100663 1535100673 1535502623 1535502663 1535502693 1535602023 1535602033 1535602043 1535602053 1535602063 1535602103 1535602123 1535602163 1535602183 1535602193
Other Recalls from Stryker Instruments Div. of Stryker C...
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1452-2022 | Class II | SurgiCount+ System Application, Software Versio... | Jun 15, 2022 |
| Z-0431-2021 | Class II | Stryker Zyphr Disposable Cranial Perforator, La... | Oct 16, 2020 |
| Z-1807-2020 | Class II | Neptune E-SEP 165mm Blade Electrode, Catalog Nu... | Mar 26, 2020 |
| Z-1402-2022 | Class II | Triton Canister System (finished part numbers F... | Jan 22, 2020 |
| Z-1097-2020 | Class II | SafeAir Telescopic Smoke Evacuation Pencil, Pr... | Jan 13, 2020 |
Frequently Asked Questions
Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.