InterFuse Tail Traction Tool recalled over sterility concerns

Recall date

January 13, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Vertebral Technologies, Inc. recalls InterFuse Tail Traction Tool, Part Number 9116. The InterFuse Tail Traction Tool is an optional Class I non-sterile reu…

Recall number

Z-1151-2017

FDA classification

Class II

Brand / firm

Vertebral Technologies, Inc.

Sold / distributed

US: IL, WI, OH, NY, MT, FL, MD, IN, TN, TX, MN. OUS: Italy, Taiwan Spain, Belgium, Canada, Netherlands, Sweden, Switzerland, Portugal, Brazil. Germany, Ireland,

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.