Z-1665-2013Class II

S-LIFT Inserter Outer Sleeve

Name: Z-1665-2013 S-LIFT Inserter Outer Sleeve
Creator: SpineFrontier, Inc.
Published: 2013-05-24
License: https://open.fda.gov/license/

SPINEFRONTIER, Inc. dba LESspine Innovations / initiated 2013-05-24 / Terminated / root cause: design

FDA source

SpineFrontier, Inc. began a recall of S-LIFT Inserter Outer Sleeve Product Usage: The Inserter Sleeve is an optional instrument to add further compression of the Inserter into the Implant during... on 2013-05-24. FDA classified it as Class II and gives the reason as "The outer sleeve would not fit over the S-LIFT Inserter assembly because the hole at the top of the sleeve handle was too small". 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-1665-2013
Classification: Class II
Status: Terminated
Initiated: 2013-05-24
Posted: 2013-07-05
Terminated: 2014-10-08
Recalling firm: SPINEFRONTIER, Inc. dba LESspine Innovations
Product: S-LIFT Inserter Outer Sleeve Product Usage: The Inserter Sleeve is an optional instrument to add further compression of the Inserter into the Implant during implantation of S-LIF Intervertebral Body Fusion Devices using bone graft to facilitate fusion of the spine of skeletally mature patients. Model: SI50003 RevA
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: The outer sleeve would not fit over the S-LIFT Inserter assembly because the hole at the top of the sleeve handle was too small.
Root cause tag: design
FDA root cause: Device Design
Action: Spine Frontier sent an Urgent Advisory Notice letter dated On June 7, 2013 to all consignees via email. The letter identified the affected product, problem and actions to be taken. The letter informed consignees that a modification has been implemented to the Outer Sleeve component of the S-LIFT Inserter and that SpineFrontier has initiated removal of the affected product from the field.. An acknowledgement form is to be signed and returned from each recipient of the Advisory Notice. Upon receipt of the acknowledgement form and RMA request for part return, replacement parts will be shipped. For questions call 978-232-3990.
Quantity in commerce: 12 devices
Distribution: USA Nationwide Distribution including the states of: FL, TX, OK, MO, NJ, MA
Product codes and lots: Lot/Serial Numbers: 47175

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1665-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1665-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-10	2013-07-04

Product code LXH

K092815Class IIS-Lif Intervertebral Body Fusion DeviceSpinefrontier, Inc. / cleared 2010-06-30

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)