Civco Medical recalls VirtuTRAX Instrument Navigators with 10 17 GA sensors due to potential failure to tighten onto instruments. Affected units have specific part numbers and lot codes.
There is potential that the VirtuTRAX device will not tighten onto the instrument to be used.
Civco Medical is recalling VirtuTRAX Instrument Navigators with 10 1:17 GA sensors because they may not tighten securely onto instruments. This could lead to improper use during medical procedures.
The VirtuTRAX device may not tighten onto surgical instruments, which could cause improper use during procedures. This might lead to ineffective treatment or complications if the instrument becomes loose during surgery.
Medical professionals using the VirtuTRAX system for surgical procedures are most at risk. Patients and staff using the recalled instruments could be affected if the device fails to secure properly.
Check for the part number 610-1080 and lot numbers A109102 through A139369 on the device. The UDI code 00841436101936 also identifies affected units.
Ensure the VirtuTRAX sensor tightens securely onto the surgical instrument before use.
The recall indicates a potential issue with the device not tightening securely, but no specific injuries have been reported. The risk is low for most users.
Check for part number 610-1080 and lot numbers A109102 through A139369 on the device. The UDI code 00841436101936 also identifies affected units.
The recall does not specify a remedy, so check with Civco Medical for guidance on safe use or potential repairs.
We’ve drafted a message you can send Civco Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0397-2022 — Civco Medical Civco Medical Hello, I own a Civco Medical that is covered by recall Z-0397-2022 from Civco Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
