Z-1664-2013Class II

BASE, S-LIFT Instrument Case

Name: Z-1664-2013 BASE, S-LIFT Instrument Case
Creator: SpineFrontier, Inc.
Published: 2013-05-17
License: https://open.fda.gov/license/

SPINEFRONTIER, Inc. dba LESspine Innovations / initiated 2013-05-17 / Terminated / root cause: design

FDA source

SpineFrontier, Inc. began a recall of BASE, S-LIFT Instrument Case Product Usage: System cases are designed to hold and secure all instrumentation to be used with a surgical system. Case and caddy... on 2013-05-17. FDA classified it as Class II and gives the reason as "The S-LIFT Instrument Case contained a bracket with peeling nylon coating". 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-1664-2013
Classification: Class II
Status: Terminated
Initiated: 2013-05-17
Posted: 2013-07-05
Terminated: 2016-05-17
Recalling firm: SPINEFRONTIER, Inc. dba LESspine Innovations
Product: BASE, S-LIFT Instrument Case Product Usage: System cases are designed to hold and secure all instrumentation to be used with a surgical system. Case and caddy components are used to contain implants intended for intervertebral body fusion and fixation of the spine.
Product code: FSM Tray, Surgical, Instrument
Reason for recall: The S-LIFT Instrument Case contained a bracket with peeling nylon coating.
Root cause tag: design
FDA root cause: Component design/selection
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 customers that a modification has been implemented for the improved durability of S-LIFT Case Brackets and that SpineFrontier has initiated removal of these cases 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
Distribution: USA Nationwide including the states of: FL, CO, Wash DC, VA, KS, TX, OH, TN, OK, CA, IL, MO, and MN.
Product codes and lots: Lot/Serial Numbers: 7201.007 and 7201.007-1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1664-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1664-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-10	2013-07-04

Product code FSM

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)