Recall archive / FDA device enforcement
VirtuTRAX Instrument Navigator, 10 17 GA VirtuTRAX — FDA record Z-0398-2022
Reported terminated
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 Oct 8, 2021. 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
- VirtuTRAX Instrument Navigator, 10 17 GA VirtuTRAX
- Reason
- There is potential that the VirtuTRAX device will not tighten onto the instrument to be used.
- Classification
- Class II
- Recalling firm
- Civco Medical Instruments Co. Inc.
- Quantity
- 599 boxes (5 units/box)
- Agency-reported status
- Terminated
- Source record identifier
- Z-0398-2022
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 | Part Number 610-1059; UDI 00841436101882 Lot Numbers: A108295, A111466, A111759, A112392, A113288, A113874, A116720, A118295, A118557, A119369, A120039, A120344, A120567, A120641, A120807, A121367, A121506, A121516, A121866, A122103, A123138, A124555, A125980, A127569, A127842, A129198, A129948, A129949, A129950, A130252, A131213, A131428, A132258, A132471, A133741, A133742, A133823, A134199, A134203, A135587, A135846, A136274, A136787, A137788, A138199, A138307, A138805, A139478, A140029, A140660, A142719, A143236, A144157, A144317, A144992, A145774 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide distribution - US Nationwide and the countries of Belgium, Canada, China (Mainland), China (Taiwan), Denmark, France, Germany, Italy, Japan, Netherlands, Singapore, South Korea, Spain, 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
- Dec 29, 2021
- Recall initiation date
- Oct 8, 2021
- Center classification date
- Dec 20, 2021
- Termination date
- Sep 30, 2024
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.