Z-1666-2013Class II

InSpan Inserter, Right Assembly; InSpan Inserter, Left Assembly

Name: Z-1666-2013 InSpan Inserter, Right Assembly; InSpan Inserter, Left Assembly
Creator: SpineFrontier, Inc.
Published: 2013-05-07
License: https://open.fda.gov/license/

SPINEFRONTIER, Inc. dba LESspine Innovations / initiated 2013-05-07 / Terminated / root cause: design

FDA source

SpineFrontier, Inc. began a recall of InSpan Inserter, Right Assembly; InSpan Inserter, Left Assembly Product Usage: Inserters are stainless steel instruments that have an inner shaft. The left and... on 2013-05-07. FDA classified it as Class II and gives the reason as "Potential for set screw to be come deformed". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1666-2013
Classification: Class II
Status: Terminated
Initiated: 2013-05-07
Posted: 2013-07-05
Terminated: 2016-01-11
Recalling firm: SPINEFRONTIER, Inc. dba LESspine Innovations
Product: InSpan Inserter, Right Assembly; InSpan Inserter, Left Assembly Product Usage: Inserters are stainless steel instruments that have an inner shaft. The left and right inserters are used in combination with each other to place the implants into the body. Inserters are used to install the InSpan Spinous Plate System for the purpose of achieving supplemental fixation.
Product code: HXX Screwdriver
Reason for recall: Potential for set screw to be come deformed.
Root cause tag: design
FDA root cause: Device Design
Action: Spine Frontier sent an Urgent Advisory Notice letter dated May 30, 2013 to all affected consignees. The letter identified the affected product. problem and actions to be taken. The letter informed consignees that a correction was implemented for InSpan Inserters. Consignees were instructed to remove parts from the field immediately for modification and that replacement Inserters will be shipped upon receipt of completed acknowledgement form and RMA request for part return. For questions call 978-232-3990.
Quantity in commerce: 61 individual inserter assemblies
Distribution: Worldwide Distribution - USA Nationwide: in the states of: FL, CO, VA, KS, TX, OH, TN, OK, CA, IL, MO, MN, Wash DC, including PR and the countries of Dominican Republic, Medico, Panama
Product codes and lots: Right Assembly: 43097, 44614, 43097R; Left Assembly: 43098, 44615, 43098R

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1666-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1666-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-10	2013-07-04

Product code HXX

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)