Z-1926-2013Class II

Rev E PedFuse Return Screw Inserter, Part Number: 11-80030 Screw inserters are instruments which capture...

Name: Z-1926-2013 Rev E PedFuse Return Screw Inserter, Part Number: 11-80030 Screw inserters are instruments which capture...
Creator: SpineFrontier, Inc.
Published: 2013-03-14
License: https://open.fda.gov/license/

SPINEFRONTIER, Inc. dba LESspine Innovations / initiated 2013-03-14 / Terminated / root cause: design

FDA source

SpineFrontier, Inc. began a recall of Rev E PedFuse Return Screw Inserter, Part Number: 11-80030 Screw inserters are instruments which capture, hold and drive pedicle screw assemblies. There is a... on 2013-03-14. FDA classified it as Class II and gives the reason as "Inserters have a set screw that fixes a collar to the inserter. The screw set can loosen and fall out of the inserter which allows the collar to slide off the proximal end of the inserter. When the collar is not in...". 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-1926-2013
Classification: Class II
Status: Terminated
Initiated: 2013-03-14
Posted: 2013-08-08
Terminated: 2015-06-03
Recalling firm: SPINEFRONTIER, Inc. dba LESspine Innovations
Product: Rev E PedFuse Return Screw Inserter, Part Number: 11-80030 Screw inserters are instruments which capture, hold and drive pedicle screw assemblies. There is a capturing feature that engages and holds the screw in place. There is also a feature used to lock the screw to the inserter before insertion of the screw. They can also be used to remove screws or back screws out. Screw inserters are used during the implantation of spinal pedicle screws intended to provide immobilization and stabilization of spinal segments in skeletally mature patients. Used in conjunction with Pedicle Screw Spinal system marketed as KRD1 PedFuse Pedicle Screw System .
Product code: HXX Screwdriver
Reason for recall: Inserters have a set screw that fixes a collar to the inserter. The screw set can loosen and fall out of the inserter which allows the collar to slide off the proximal end of the inserter. When the collar is not in place the locking sleeve can also slide off the inserter.
Root cause tag: design
FDA root cause: Device Design
Action: Spine Frontier sent an email dated December 10, 2012, to the affected customers that a Pedfuse Inserter with part number PM3979 needed to be returned. Further questions please call (978) 232-3990.
Quantity in commerce: 8
Distribution: Distribution only in Texas.
Product codes and lots: Lot Number: PM3979

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1926-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1926-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-14	2013-08-08

Product code HXX

K092420Class IIKrd1 Pedicle Screw SystemSpinefrontier, Inc. / cleared 2009-11-19

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)