TrackX Insight Base Modular Instrument Tracker, 5L, REF #604-3TX, Sterile; and TrackX Insight Base Modular Instrument T
Summary
The FDA issued a Class II for TrackX Insight Base Modular Instrument Tracker, 5L, REF #604-3TX, Sterile; and by Trackx Technology Inc. Reason: The device is breaking and falling off the Nuvasive T-Handle with Hudson Adapter on certain Nuvasive XLIF instruments during surgery when malleted..
Details
Source
Device Recall
External ID
Z-1107-2023
Action Date
2023-02-15
Status
Ongoing
Category
device
Product Description
TrackX Insight Base Modular Instrument Tracker, 5L, REF #604-3TX, Sterile; and TrackX Insight Base Modular Instrument Tracker, 6.5L, Model #605-3TX, Sterile.
Lot/Code Info: Insight Base -5L - Lot #2206001, exp. 6/1/2025, UDI 00857088008431; Insight Base 6.5L - Lot #2202002, exp. 2/1/20024, UDI 00857088008448.
Quantity Affected: 464 devices
Reason for Recall
The device is breaking and falling off the Nuvasive T-Handle with Hudson Adapter on certain Nuvasive XLIF instruments during surgery when malleted.
Distribution
US Nationwide distribution in the states of AZ, FL, LA, NC, PA, VA, WA, WI.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-10-24
Company
Hillsborough, NC
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 163 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Trackx Technology Inc has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Trackx Technology Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Trackx Technology Inc have FDA actions?
Trackx Technology Inc has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1107-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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