Z-0412-2013Class II

Spine Frontier Inspan compressors Part Number: 11-60004. Inspan compressors provide pressure to drive spikes...

Name: Z-0412-2013 Spine Frontier Inspan compressors Part Number: 11-60004. Inspan compressors provide pressure to drive spikes...
Creator: SpineFrontier, Inc.
Published: 2012-08-28
License: https://open.fda.gov/license/

SPINEFRONTIER, Inc. dba LESspine Innovations / initiated 2012-08-28 / Terminated / root cause: design

FDA source

SpineFrontier, Inc. began a recall of Spine Frontier Inspan compressors Part Number: 11-60004. Inspan compressors provide pressure to drive spikes of Inspan implants into the spinous process bone... on 2012-08-28. FDA classified it as Class II and gives the reason as "Inspan Compressors may break at weld causing a loss of compression". 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-0412-2013
Classification: Class II
Status: Terminated
Initiated: 2012-08-28
Posted: 2012-11-21
Terminated: 2015-06-11
Recalling firm: SPINEFRONTIER, Inc. dba LESspine Innovations
Product: Spine Frontier Inspan compressors Part Number: 11-60004. Inspan compressors provide pressure to drive spikes of Inspan implants into the spinous process bone, resulting in fixation of the implant.
Product code: KWP Appliance, Fixation, Spinal Interlaminal
Reason for recall: Inspan Compressors may break at weld causing a loss of compression
Root cause tag: design
FDA root cause: Device Design
Action: Spine Frontier issued e-mail notices to customers on May 14, 2012 advising of the potential for breakage. Units were replaced with weld free design.
Quantity in commerce: 17 units
Distribution: Worldwide Distribution-USA (nationwide) including PR and the states of FL, MA, MO, OK, and TX, and the country of Mexico.
Product codes and lots: Lot Numbers: SFP02323, SFP02323R, and SFP02323RR

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0412-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0412-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-21

Product code KWP

K093438Class IIParadigm Interspinous Fusion PlateParadigm Spine, LLC / cleared 2010-10-06

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)