Z-1151-2017Class II

InterFuse Tail Traction Tool, Part Number 9116. The InterFuse Tail Traction Tool is an optional Class I...

Name: Z-1151-2017 InterFuse Tail Traction Tool, Part Number 9116. The InterFuse Tail Traction Tool is an optional Class I...
Creator: Vertebral Technologies, Inc.
Published: 2017-01-13
License: https://open.fda.gov/license/

Vertebral Technologies, Inc. / initiated 2017-01-13 / Terminated / root cause: manufacturing process

FDA source

Vertebral Technologies, Inc. began a recall of 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... on 2017-01-13. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1151-2017
Classification: Class II
Status: Terminated
Initiated: 2017-01-13
Posted: 2017-02-08
Terminated: 2017-10-05
Recalling firm: Vertebral Technologies, Inc.
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.
Product code: LXH Orthopedic Manual Surgical Instrument
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Consignees 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 [email protected] to obtain a replacement instrument.
Quantity in commerce: 63 pieces
Distribution: 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,
Product codes and lots: Lot: 110512-02, 110718-01, 110831-02, 120214-01, 120403-018, 120420-07, 120711-02, 120911-06

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1151-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1151-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-15	2017-02-08

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)