Z-0417-2013Class II

S-Lift Implant Guides (also known as S-LIF) Compressor Part Number: 11-50223

Name: Z-0417-2013 S-Lift Implant Guides (also known as S-LIF) Compressor Part Number: 11-50223
Creator: SpineFrontier, Inc.
Published: 2012-08-22
License: https://open.fda.gov/license/

SPINEFRONTIER, Inc. dba LESspine Innovations / initiated 2012-08-22 / Terminated / root cause: labeling and UDI

FDA source

SpineFrontier, Inc. began a recall of S-Lift Implant Guides (also known as S-LIF) Compressor Part Number: 11-50223 Product Usage: Surgical Guides allow a surgeon to place implants into tight... on 2012-08-22. FDA classified it as Class II and gives the reason as "When using the optional S-LIFT (also known as S-LIF) Implant Guides without stops, there is a known risk of moving the Implant Guides, and possibly the implant, too far into the disc space creating the potential for...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0417-2013
Classification: Class II
Status: Terminated
Initiated: 2012-08-22
Posted: 2012-11-21
Terminated: 2015-06-11
Recalling firm: SPINEFRONTIER, Inc. dba LESspine Innovations
Product: S-Lift Implant Guides (also known as S-LIF) Compressor Part Number: 11-50223 Product Usage: Surgical Guides allow a surgeon to place implants into tight spaces, such as a vertebral disc space, without having the implant contact the surrounding bone or tissue. In the case of S-LIFT Implant Guides, they are used to place vertebral bodies into the disc space without the body contacting the superior or inferior vertebrae.
Product code: MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Reason for recall: When using the optional S-LIFT (also known as S-LIF) Implant Guides without stops, there is a known risk of moving the Implant Guides, and possibly the implant, too far into the disc space creating the potential for injury to the patient. The instructions for Use for the S-Lift Implant Guides will be amended to add the following warning: "Care is to be taken to not over insert the Implant Guides
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: Spine Frontier issued a Correction Notice Letter August 22, 2012 to all affected customers to update the Instructions for Use. The letter identified the affected product, problem and actions to be taken. Customers were Instructed to remove the Instructions for Use they currently have and replace them with the update. The letter instructs customers to complete and return the Response Form to 978-232-3990.
Quantity in commerce: 19 units
Distribution: US Nationwide including the states of: MA and TX.
Product codes and lots: Lot Numbers: 012064-001

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0417-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0417-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-21

Product code MAX

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)