FDAClass IIDecember 29, 2021

VirtuTRAX Instrument Navigator recall

VirtuTRAX Instrument Navigator, 10 17 GA VirtuTRAX

Why was VirtuTRAX Instrument Navigator recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
VirtuTRAX Instrument Navigator, 10 17 GA VirtuTRAX
Recalling firm
Civco Medical Instruments Co. Inc.
Quantity
599 boxes (5 units/box)
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.
Recall date
December 29, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls