Agency classClass IIOur severity:High FDA (Devices)·Z-0398-2022·Announced 2021-12-29

VirtuTRAX Instrument Navigator devices may not tighten properly

Civco Medical Instruments is recalling VirtuTRAX Instrument Navigator devices due to a potential mechanical failure that could prevent proper securing of instruments. The device may not tighten onto the instrument as intended.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a risk-of-harm medical device where potential injury has not yet been reported. It is classified as FDA Class II, but without reported hospitalization or injury cases, it does not meet the Severe threshold. The mechanical failure could impact patient safety if the device fails to secure instruments during procedures.

Plain-English summary

Civco Medical Instruments Co. Inc. is recalling the VirtuTRAX Instrument Navigator, 10 17 GA model, a medical instrument navigator. The recall is due to a potential mechanical failure in which the device may not tighten properly onto the instrument to be used, potentially preventing proper securing during medical procedures.

Approximately 599 boxes containing 5 units each have been affected by this recall. The devices have been distributed worldwide, including throughout the United States and internationally to Belgium, Canada, China (Mainland and Taiwan), Denmark, France, Germany, Italy, Japan, Netherlands, Singapore, South Korea, Spain, and Thailand.

The recalled VirtuTRAX Instrument Navigator devices are identified by Part Number 610-1059, UDI 00841436101882, and specific lot numbers from A108295 to A145774. Customers and healthcare providers should verify lot numbers against the complete list maintained by the FDA and the manufacturer.

The recalled product

Product: VirtuTRAX Instrument Navigator, 10 17 GA VirtuTRAX
Manufacturer: Civco Medical Instruments Co. Inc.
Category: Medical Device — Surgical/Procedural Instrument
Hazard: mechanical-failure
functional-failure

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

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

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by Civco Medical Instruments Co. Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Same manufacturer · Civco Medical Instruments Co. Inc.

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Same hazard · mechanical failure