Maestro Air Motor Pneumatic cranial drill motor
Medical device recall Z-1939-2016. Published in FDA’s Enforcement Report on Jun 15, 2016.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jun 15, 2016. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- 22 states named in where it went
- 189 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are 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.
189, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,990 characters
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…
FDA’s list runs to 2,110 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Domestic only: AL AR CA FL GA IL IN KS KY MD MI MO NC NM OH OK SC TN TX VA WA WI
The states and territories these words name
22 states and territories.
Every one of them
- Alabama
- Arkansas
- California
- Florida
- Georgia
- Illinois
- Indiana
- Kansas
- Kentucky
- Maryland
- Michigan
- Missouri
- North Carolina
- New Mexico
- Ohio
- Oklahoma
- South Carolina
- Tennessee
- Texas
- Virginia
- Washington
- Wisconsin
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Apr 28, 2016.
- FDA classified it on Jun 9, 2016.
- FDA’s Enforcement Report published it on Jun 15, 2016.
- FDA terminated it on Mar 24, 2017.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Stryker Instruments Div. of Stryker Corporation, of Portage, MI.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 2,110 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.