Recall archive / FDA device enforcement
Stryker 2.3mm Tapered Router, Catalog no. 5820-071-023 instrument used in craniotomy procedures. — FDA record Z-1478-2022
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jun 24, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Stryker 2.3mm Tapered Router, Catalog no. 5820-071-023 instrument used in craniotomy procedures.
- Reason
- There is a potential for the core diameter to be undersized, which may lead to the router breaking. A break can lead to unintended metal fragments in the surgical site, resulting in the potential for surgical intervention or damage to critical neurological or vascular structures.
- Classification
- Class II
- Recalling firm
- Stryker Instruments
- Quantity
- 543
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1478-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI-DI (GTIN): 07613327294910 Affected Lots: 22011017 21330017 20216017 20140017 20139027 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide distribution - US Nationwide distribution in the states of Arizona, California, Florida, Georgia, Iowa, Michigan, Missouri, New Mexico, North Carolina, Ohio, Texas, Virginia and the countries of Canada, Netherlands, and Thailand.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Aug 3, 2022
- Recall initiation date
- Jun 24, 2022
- Center classification date
- Jul 28, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.