Reported Feb 15, 2017 · Terminated
InterFuse Tail Traction Tool, Part Number 9116. The InterFuse Tail Traction Tool is an optional Class I non-sterile…
Vertebral Technologies, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Vertebral Technologies, Inc. · 13845 Industrial Park Blvd · Minneapolis, MN · 55441-3746
Is this the product you have?
- 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.
- Lot codes and dates
- Lot
110512-02110718-01110831-02120214-01120403-018120420-07120711-02120911-06
- Lot
- Amount recalled
- 63 pieces
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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