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Recall Observatory FDA recall evidence

Device product

VirtuTRAX Instrument Navigator, Sensor with 10 17 GA VirtutTRAX

Z-0397-2022

October 08, 2021

Class II

Product summary

Firm
Civco Medical Instruments Co. Inc.
Event
Event 88906
Status
Terminated
Classification
Class II
Quantity
18 boxes (5 units/box)
Official record key
device-enforcement:Z-0397-2022

Official wording

Reason: There is potential that the VirtuTRAX device will not tighten onto the instrument to be used.

Code information: Part Number 610-1080; UDI 00841436101936; Lot Numbers: A109102, A109175, A121363, A129087, A129088, A131042, A133436, A134220, A138099, A139369, A140674, A141818

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    There is potential that the VirtuTRAX device will not tighten onto the instrument to be used.