Z-0553-2014Class II

PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REset Part #11-80110 The PedFuse Screw Inserter...

Name: Z-0553-2014 PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REset Part #11-80110 The PedFuse Screw Inserter...
Creator: SpineFrontier, Inc.
Published: 2013-11-20
License: https://open.fda.gov/license/

SPINEFRONTIER, Inc. dba LESspine Innovations / initiated 2013-11-20 / Terminated / root cause: design

FDA source

SpineFrontier, Inc. began a recall of PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REset Part #11-80110 The PedFuse Screw Inserter 05-7 REset, Screw Inserter 05-7 REspond, and Screw... on 2013-11-20. FDA classified it as Class II and gives the reason as "Screw inserters may not mate properly with hex interface of the screws". 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-0553-2014
Classification: Class II
Status: Terminated
Initiated: 2013-11-20
Posted: 2013-12-20
Terminated: 2018-06-26
Recalling firm: SPINEFRONTIER, Inc. dba LESspine Innovations
Product: PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REset Part #11-80110 The PedFuse Screw Inserter 05-7 REset, Screw Inserter 05-7 REspond, and Screw Inserter 08-9 REset are used as a screw capture, screw driver, and screw insertion tool in the PedFuse system.
Product code: MNI Orthosis, Spinal Pedicle Fixation
Reason for recall: Screw inserters may not mate properly with hex interface of the screws.
Root cause tag: design
FDA root cause: Device Design
Action: The firm, SpineFrontier, Inc., sent an "Urgent PedFuse Screw Inserter Voluntary Recall Notification" letter on November 20, 2013 to its consignees/customers. The letter described the product, problem and actions to be taken. The customers were instructed to initiate the immediate return of the recalled products and to complete a recall ACKNOWLEDGEMENT FORM via fax or email to: SpineFrontier, Inc., 500 Cummings Center, Suite 3500, Beverly MA 01915, Attn: Customer Service; Fax: 978-232-3991; email: [email protected]. Please feel free to contact at 978-232-3990 Monday thru Friday 8:30AM to 5:30PM Eastern with any questions.
Quantity in commerce: 4
Distribution: US Distribution to states of:Texas, New York, Illinois, Ohio, Virginia, Washington D.C., and Florida. .
Product codes and lots: VM13221-34457

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0553-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0553-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-01	2013-12-20
Z-0554-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-01	2013-12-20
Z-0555-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-01	2013-12-20

Product code MNI

K123164Class IISpinefrontier Pedfuse Pedicle Screw SystemSpinefrontier, Inc. / cleared 2013-02-15

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)