The Recall Desk
HighFDA (Devices)·Z-0395-2022·Announced 2021-12-29

VirtuTRAX Instrument Navigator Sensor May Fail to Tighten

Civco Medical recalls VirtuTRAX Instrument Navigator sensors that may fail to tighten onto instruments during use. No injuries reported.

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 with potential device malfunction and no reported injuries or adverse events. Meets rubric criteria for High severity: risk-of-harm product where injury has not yet been reported.

Plain-English summary

Civco Medical Instruments Co. Inc. is recalling the VirtuTRAX Instrument Navigator with 14 Ga VirtutTRAX sensor. The device is used to guide instruments during surgical procedures.

There is a potential that the VirtuTRAX device will not tighten properly onto the instrument being used.

The recall affects 52 boxes containing a total of 260 units with the following lot numbers: A117795, A119539, A121993, A129844, A131074, A131075, A131690, and A142178. The devices were distributed worldwide, including throughout the United States and internationally to Belgium, Canada, China, Denmark, France, Germany, Italy, Japan, Netherlands, Singapore, South Korea, Spain, and Thailand.

Healthcare facilities and individuals with affected units should discontinue use immediately and contact Civco Medical Instruments Co. Inc. for instructions regarding device replacement or return.

The recalled product

Product
VirtuTRAX Instrument Navigator, Sensor with 14 Ga VirtutTRAX
Manufacturer
Civco Medical Instruments Co. Inc.
Category
Medical Device — Surgical Navigation System
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 (10)

  • Part Number 5350925
  • UDI 00841436100892
  • Lot Numbers: A117795
  • A119539
  • A121993
  • A129844
  • A131074
  • A131075
  • A131690
  • A142178

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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