Z-1565-2014Class II

SpineFrontier S-Lift Lock Shaft Inserter, an instrument used with S-LIFT Intervertebral Body Fusion Device in...

Name: Z-1565-2014 SpineFrontier S-Lift Lock Shaft Inserter, an instrument used with S-LIFT Intervertebral Body Fusion Device in...
Creator: SpineFrontier, Inc.
Published: 2011-12-23
License: https://open.fda.gov/license/

SPINEFRONTIER, Inc. dba LESspine Innovations / initiated 2011-12-23 / Terminated / root cause: design

FDA source

SpineFrontier, Inc. began a recall of SpineFrontier S-Lift Lock Shaft Inserter, an instrument used with S-LIFT Intervertebral Body Fusion Device in spinal fusion surgery. Product Usage: The S-Lift... on 2011-12-23. FDA classified it as Class II and gives the reason as "It has been verified through field use that there are two possible breakages that may occur when using SI50001 Revision D Lock Shaft Inserter, possibly resulting in instrument fragments entering the sterile field...". 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-1565-2014
Classification: Class II
Status: Terminated
Initiated: 2011-12-23
Posted: 2014-05-07
Terminated: 2014-05-20
Recalling firm: SPINEFRONTIER, Inc. dba LESspine Innovations
Product: SpineFrontier S-Lift Lock Shaft Inserter, an instrument used with S-LIFT Intervertebral Body Fusion Device in spinal fusion surgery. Product Usage: The S-Lift Lock Shaft SI50001 mates with SI50002, Implant Inserter, to aid in securing the implant to the whole implant inserter assembly, SI50000.
Product code: MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Reason for recall: It has been verified through field use that there are two possible breakages that may occur when using SI50001 Revision D Lock Shaft Inserter, possibly resulting in instrument fragments entering the sterile field: Impact Cap: The impact cap on the Lock Shaft Inserter can shear off under high-impact force during insertion and removal. Pin: The pin used to guide the Lock Shaft Inserter into the ma
Root cause tag: design
FDA root cause: Device Design
Action: Spine Frontier sent an Urgent Notification dated December 23, 2011, consignees. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete the attached acknowledgement form. For questions call 866-914-7717
Quantity in commerce: 30 devices
Distribution: US Nationwide - OR, FL, MA, TX, CO, OK, IL, and MO
Product codes and lots: S-Lift Lock Shaft Part number; SI50001 Revisions: A, B Lots: 42613, 2478901R, 42615, 7625701

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1565-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1565-2014	Class II	Terminated	Voluntary: Firm initiated	2014-05-14	2014-05-07

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)