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FDA (Device enforcement)Recalled 2021-10-08closedclass ii

Civco Medical Instruments Co. Inc.: VirtuTRAX Instrument Navigator, 10 17 GA VirtuTRAX

Is my product affected?

VirtuTRAX Instrument Navigator, 10 17 GA VirtuTRAX

  • UPC 00841436101882

Check against the official notice below — it lists the full affected range.

What happened

Civco Medical Instruments Co. Inc. is recalling the VirtuTRAX Instrument Navigator (10 17 GA model, Part Number 610-1059) because the device may fail to tighten properly onto instruments during use. The recall affects 599 boxes containing 5 units each, distributed worldwide including across the United States and in Belgium, Canada, China, Denmark, France, Germany, Italy, Japan, Netherlands, Singapore, South Korea, Spain, and Thailand.

The affected devices are identifiable by UDI 00841436101882 and specific lot numbers ranging from A108295 through A145774. The source does not specify a remedy or corrective action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

Reason for recall: There is potential that the VirtuTRAX device will not tighten onto the instrument to be used. 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. Quantity: 599 boxes (5 units/box) Lot/code info: 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

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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