Z-0274-2014Class II

S-LIFT Extension Shims Extension shims are manufactured from grade 5 titanium and are curved, rectangular...

Name: Z-0274-2014 S-LIFT Extension Shims Extension shims are manufactured from grade 5 titanium and are curved, rectangular...
Creator: SpineFrontier, Inc.
Published: 2013-08-28
License: https://open.fda.gov/license/

SPINEFRONTIER, Inc. dba LESspine Innovations / initiated 2013-08-28 / Terminated / root cause: design

FDA source

SpineFrontier, Inc. began a recall of S-LIFT Extension Shims Extension shims are manufactured from grade 5 titanium and are curved, rectangular slabs which have four protrusions used for... on 2013-08-28. FDA classified it as Class II and gives the reason as "Fit variation among all lots of S-LIFT extension shims with corresponding retractor blades. The firm's investigation revealed that extension shims may not fit down all retractor blades". 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-0274-2014
Classification: Class II
Status: Terminated
Initiated: 2013-08-28
Posted: 2013-11-14
Terminated: 2018-09-13
Recalling firm: SPINEFRONTIER, Inc. dba LESspine Innovations
Product: S-LIFT Extension Shims Extension shims are manufactured from grade 5 titanium and are curved, rectangular slabs which have four protrusions used for ratcheting. They come in straight and pointed varieties, either with or without a tab containing an additional bend. Extension shims are designed to slide down retractor blades, and are optional retractor components utilized during lumbar interbody fusion procedures. They are intended to manipulate tissue and prevent tissue from interfering inside the surgical field.
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: Fit variation among all lots of S-LIFT extension shims with corresponding retractor blades. The firm's investigation revealed that extension shims may not fit down all retractor blades.
Root cause tag: design
FDA root cause: Device Design
Action: SpineFrontier sent an Urgent Voluntary Recall letter dated August 28, 2013, to all affected customers. The letter identified teh product, the problem, and the action to be taken by the customer. Customers were asked to initiate the immediate return of the parts noted and complete an acknowledgement form and return it to SpineFrontier via fax or email. Customers with questions were instructed to call 978-232-3990. For questions regarding this recall call 978-232-3990.
Quantity in commerce: 67
Distribution: Nationwide Distribution including FL, TX, OK, MO, IL, OH, VA, OR, CO, KS, CT
Product codes and lots: Part Number/Lot Number: 11-50109 43092R; 11-50109 46415; 11-50109 CT12H013; 11 -50109-1 46415-1; 11-50110 43089; 11-50110 43089R; 11-50110 46416; 11-50110-1 46416-1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0274-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0274-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-14

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)