VirtuTRAX Instrument Navigator, Sensor with 10 17 GA VirtutTRAX
FDA Recall Z-0397-2022 · Posted None
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Recalling FirmCivco Medical Instruments Co. Inc.
Recall StatusTerminated
Product CodeIYO
Date Initiated2021-10-08
Date Terminated2024-09-30
Product Quantity18 boxes (5 units/box)
Reason for Recall
There is potential that the VirtuTRAX device will not tighten onto the instrument to be used.
Firm Action
The firm distributed an "URGENT: MEDICAL DEVICE RECALL" notice on 10/21/2021 by email. The notice explained the problem and requested acknowledgement of the notice. Entities further distributing the products were directed to notify those to whom the devices were distributed. The firm will be replacing the units.
Root Cause
Device Design
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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