TrackX recalls specific surgical instrument trackers that may fall off during surgery when used with certain Nuvasive XLIF instruments, posing a risk of injury.
The device is breaking and falling off the Nuvasive T-Handle with Hudson Adapter on certain Nuvasive XLIF instruments during surgery when malleted.
TrackX is recalling two types of surgical instrument trackers that can fall off during surgery when used with specific Nuvasive XLIF instruments. This hazard could lead to injury if the device falls and impacts the surgical site.
The device can break and fall off the Nuvasive T-Handle with Hudson Adapter during surgery when malleted on certain Nuvasive XLIF instruments. This could cause injury if the device falls and impacts the surgical site.
Surgical teams using TrackX Insight Base Modular Instrument Trackers with Nuvasive XLIF instruments are most at risk. Patients undergoing surgery with these specific instruments may be affected.
Check for the model numbers 604-3TX (5L) or 605-3TX (6.5L) with lot numbers 2206001 or 2202002. These trackers were sold with specific expiration dates and unique identifiers.
Identify the model number and lot number to confirm if your device is affected.
The device can break and fall off the Nuvasive T-Handle with Hudson Adapter during surgery when malleted on certain Nuvasive XLIF instruments, posing a risk of injury.
Check for model numbers 604-3TX (5L) or 605-3TX (6.5L) with lot numbers 2206001 or 2202002.
The recall does not specify a remedy, so contact Trackx Technology Inc for further instructions.
We’ve drafted a message you can send Trackx to request your refund or repair — edit it as you like.
Subject: Recall Z-1107-2023 — Trackx Trackx Hello, I own a Trackx that is covered by recall Z-1107-2023 from Trackx. 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.
