Recall Z-1107-2023 ยท OWB Interventional Fluoroscopic X-Ray System
Trackx Technology Inc
TrackX Insight Base Modular Instrument Tracker, 5L, REF #604-3TX, Sterile; and TrackX Insight Base Modular Instrument Tracker, 6.5L, Model #605-3TX, Sterile.
| Date | Feb 9, 2023 (initiated Oct 24, 2022) |
| Status | Terminated |
| Reason | The device is breaking and falling off the Nuvasive T-Handle with Hudson Adapter on certain Nuvasive XLIF instruments during surgery when malleted. |
| Root cause | Device Design |
| Action | The recall was initiated via phone call on 10/24/2022 and 10/27/2022 (as well as subsequent in-person meetings) to two of the physicians who use the product in the affected application. The physicians were notified that the products can fragment when attached to a T-Handle and Nuvasive XLIF disectomy instruments while malleting and TrackX is limiting the use of those two bases to situations in the Nuvasive XLIF and Lateral Interbody procedures that do not require the malleting of the T-handle. The product is to be used in a limited manner and not on the Nuvasive T-Handle with Nuvasive XLIF |
| Quantity | 464 devices |
| Distribution | US Nationwide distribution in the states of AZ, FL, LA, NC, PA, VA, WA, WI. |
| FDA record | Open on fda.gov |