Recall Z-1151-2017— Vertebral Technologies, Inc.
Class II · Terminated
Class II FDA medical device recall by Vertebral Technologies, Inc., initiated 2017-01-13, terminated 2017-10-05. FDA's recall record names no specific 510(k) clearance for this event. Product: InterFuse Tail Traction Tool, Part Number 9116. The InterFuse Tail Traction Tool is an optional Class I non-sterile reusable instrument that can be used to assist with module locking of the InterFuse S or InterFuse T implant system. The system has a modular design to allow the device to be assembled within the disc space to minimize the surgical window, while providing a footprint that approximates the excised nucleus.. Reason: Fit issues have been identified with the Tail Traction Tool (PN 9116) when used with the Interfuse T tailed implant. The InterFuse T Tail may not fit into the Thru Hole in the instrument..
- Recalling firm
- Vertebral Technologies, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-01-13
- Terminated
- 2017-10-05
- Firm location
- Minneapolis, MN, United States
Product description
InterFuse Tail Traction Tool, Part Number 9116. The InterFuse Tail Traction Tool is an optional Class I non-sterile reusable instrument that can be used to assist with module locking of the InterFuse S or InterFuse T implant system. The system has a modular design to allow the device to be assembled within the disc space to minimize the surgical window, while providing a footprint that approximates the excised nucleus.
Reason for recall
Fit issues have been identified with the Tail Traction Tool (PN 9116) when used with the Interfuse T tailed implant. The InterFuse T Tail may not fit into the Thru Hole in the instrument.
Data sourced from openFDA. This site is unofficial and independent of the FDA.