The Recall Desk
HighFDA (Devices)·Z-0397-2022·Announced 2021-12-29

VirtuTRAX Instrument Navigator Sensor May Fail to Tighten Properly

Civco Medical Instruments is recalling VirtuTRAX Instrument Navigator sensors because they may fail to tighten properly onto surgical instruments. This functional defect could affect safe use during medical procedures.

What this means for you

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: FDA Class II recall involving a medical device with a functional defect that could compromise safe operation. The device may fail to tighten onto surgical instruments, creating a risk to patients during medical procedures. No injuries or illnesses have been reported.

Plain-English summary

Civco Medical Instruments Co. Inc. is recalling VirtuTRAX Instrument Navigator Sensor devices, which are used to guide and secure surgical instruments during medical procedures. The recalled devices include 90 units (18 boxes of 5 units each) distributed worldwide, including throughout the United States and 14 other countries.

The devices are subject to this recall because they may fail to tighten properly onto the instrument they are meant to secure. This functional defect could affect the device's ability to maintain secure positioning during medical procedures.

The recall affects customers and healthcare facilities that received units with the following lot numbers: A109102, A109175, A121363, A129087, A129088, A131042, A133436, A134220, A138099, A139369, A140674, A141818. Affected users should contact Civco Medical Instruments for instructions regarding their specific units.

This is a Class II recall. The affected part number is 610-1080, and the UDI is 00841436101936.

The recalled product

Product
VirtuTRAX Instrument Navigator, Sensor with 10 17 GA VirtutTRAX
Manufacturer
Civco Medical Instruments Co. Inc.
Category
Medical Device — Surgical Instrument
Hazard

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 (14)

  • Part Number 610-1080
  • UDI 00841436101936
  • Lot Numbers: A109102
  • A109175
  • A121363
  • A129087
  • A129088
  • A131042
  • A133436
  • A134220
  • A138099
  • A139369
  • A140674
  • A141818

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 →

Related recalls

Same manufacturer · Civco Medical Instruments Co. Inc.

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Same hazard · improper attachment

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