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Recall Observatory FDA recall evidence

Device product

VirtuTRAX Instrument Navigator, 14 Ga VirtuTRAX

Z-0396-2022

October 08, 2021

Class II

Product summary

Firm
Civco Medical Instruments Co. Inc.
Event
Event 88906
Status
Terminated
Classification
Class II
Quantity
9 boxes (5 units/box)
Official record key
device-enforcement:Z-0396-2022

Official wording

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

Code information: Part Number 610-1153; UDI 00841436102285; Lot Numbers: A122182, A131167, A131689, A131691, A141823

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.