The Recall Desk
ModerateFDA (Devices)·Z-0396-2022·Announced 2021-12-29

VirtuTRAX Instrument Navigator recalled for potential tightening failure

Civco Medical Instruments is recalling VirtuTRAX Instrument Navigator devices due to a potential defect that may prevent proper tightening onto medical instruments. The device was distributed worldwide.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is a Class II device recall with no reported injuries or illnesses. The device may fail to tighten properly onto instruments, representing a functional defect without documented harm.

Plain-English summary

Civco Medical Instruments Co. Inc. is recalling the VirtuTRAX Instrument Navigator, 14 Ga VirtuTRAX. The recall is prompted by a potential defect in which the device may not tighten properly onto the instrument it is designed to secure.

The affected devices were distributed in the United States and internationally to Belgium, Canada, China (Mainland), China (Taiwan), Denmark, France, Germany, Italy, Japan, Netherlands, Singapore, South Korea, Spain, and Thailand. The recall includes 45 units total distributed across 9 boxes (5 units per box). Affected lot numbers are A122182, A131167, A131689, A131691, and A141823.

The recalled product

Product
VirtuTRAX Instrument Navigator, 14 Ga VirtuTRAX
Manufacturer
Civco Medical Instruments Co. Inc.
Hazard
  • tightening-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 (7)

  • Part Number 610-1153
  • UDI 00841436102285
  • Lot Numbers: A122182
  • A131167
  • A131689
  • A131691
  • A141823

Distribution

Distributed nationwide across the United States.