Surgical instrument tracker recalled for structural failure during use
Trackx Technology is recalling 464 units of its Insight Base Modular Instrument Tracker because the device breaks and falls off from surgical instruments during procedures. No injuries have been reported.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: This is an FDA Class II recall involving a confirmed structural defect that occurs during active surgery. No injuries or illnesses have been reported, but the device failure during surgery presents a clear risk of harm, meeting the rubric criterion for Score 3: 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Trackx Technology Inc is recalling 464 units of the TrackX Insight Base Modular Instrument Tracker (models 5L, REF #604-3TX and 6.5L, Model #605-3TX) due to a structural failure defect. The device breaks and falls off from the Nuvasive T-Handle with Hudson Adapter on certain Nuvasive XLIF instruments during surgical procedures when struck with a mallet.
The affected trackers were distributed nationwide in Arizona, Florida, Louisiana, North Carolina, Pennsylvania, Virginia, Washington, and Wisconsin. The recalled lots are: Insight Base 5L Lot #2206001 (expiration 6/1/2025, UDI 00857088008431) and Insight Base 6.5L Lot #2202002 (expiration 2/1/2024, UDI 00857088008448).
No injuries or illnesses have been reported to date. However, because the device can separate from surgical instruments during active surgery, there is a potential risk of harm to patients undergoing XLIF procedures.
Healthcare facilities and medical professionals using these products should immediately stop using the affected devices and contact Trackx Technology Inc or the FDA with questions or concerns.
The recalled product
- Product
- TrackX Insight Base Modular Instrument Tracker, 5L, REF #604-3TX, Sterile; and TrackX Insight Base Modular Instrument Tracker, 6.5L, Model #605-3TX, Sterile.
- Manufacturer
- Trackx Technology Inc
- Affected units
- 464
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 (6)
- Insight Base -5L - Lot #2206001
- exp. 6/1/2025
- UDI 00857088008431
- Insight Base 6.5L - Lot #2202002
- exp. 2/1/20024
- UDI 00857088008448.
Distribution
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