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Recall Observatory FDA recall evidence

Device 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.

Z-1151-2017

January 13, 2017

Class II

Product summary

Firm
Vertebral Technologies, Inc.
Event
Event 76275
Status
Terminated
Classification
Class II
Quantity
63 pieces
Official record key
device-enforcement:Z-1151-2017

Official wording

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.

Code information: Lot: 110512-02, 110718-01, 110831-02, 120214-01, 120403-018, 120420-07, 120711-02, 120911-06

Distribution pattern: 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,

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.