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U.S. Department of Health and Human Services

Class 2 Device Recall InterFuse Tail Traction Tool

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 Class 2 Device Recall InterFuse Tail Traction Toolsee related information
Date Initiated by FirmJanuary 13, 2017
Create DateFebruary 08, 2017
Recall Status1 Terminated 3 on October 05, 2017
Recall NumberZ-1151-2017
Recall Event ID 76275
Product Classification Orthopedic manual surgical instrument - Product Code LXH
ProductInterFuse 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.
Code Information Lot: 110512-02, 110718-01, 110831-02, 120214-01, 120403-018, 120420-07, 120711-02, 120911-06
FEI Number 3007617183
Recalling Firm/
Manufacturer		 Vertebral Technologies, Inc.
13845 Industrial Park Blvd
Minneapolis MN 55441-3746
For Additional Information ContactCustomer Service
877-912-5401
Manufacturer 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.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionConsignees were sent via email a VTI "Advisory Notice" letter. The letter listed the Concern, Impact, Alternate Methods, Affected Lots, and Your Responsibility. Consignees were requested to acknowledge receipt of this notice, Discontinue use of the Tail Traction Tool when implanting the InterFuse T tailed implant, Notify individuals that may potentially use the device and alternate module assembly methods. Advise consignees to contact Customer Service (1-877-912-5401 in US , +-952-912-5400 outside US or customerservice@vti-spine.com to obtain a replacement instrument.
Quantity in Commerce63 pieces
DistributionUS: IL, WI, OH, NY, MT, FL, MD, IN, TN, TX, MN. OUS: Italy, Taiwan Spain, Belgium, Canada, Netherlands, Sweden, Switzerland, Portugal, Brazil. Germany, Ireland,
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
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