Z-0544-2014Class II

PedFuse Reset Screw; Model: 01-80115-55 The PedFuse Reset pedicle screw implants intended to be used to help...

Name: Z-0544-2014 PedFuse Reset Screw; Model: 01-80115-55 The PedFuse Reset pedicle screw implants intended to be used to help...
Creator: SpineFrontier, Inc.
Published: 2013-10-18
License: https://open.fda.gov/license/

SPINEFRONTIER, Inc. dba LESspine Innovations / initiated 2013-10-18 / Terminated / root cause: software

FDA source

SpineFrontier, Inc. began a recall of PedFuse Reset Screw; Model: 01-80115-55 The PedFuse Reset pedicle screw implants intended to be used to help provide immobilization and stabilization of spinal... on 2013-10-18. FDA classified it as Class II and gives the reason as "During routine servicing, it was discovered that one 8mmx55mm Reset screw was assembled with an 8mm tulip head and a 9mm screw. The implant should have consisted of an 8mm tulip head and an 8mm screw. A recall was...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0544-2014
Classification: Class II
Status: Terminated
Initiated: 2013-10-18
Posted: 2013-12-19
Terminated: 2016-08-22
Recalling firm: SPINEFRONTIER, Inc. dba LESspine Innovations
Product: PedFuse Reset Screw; Model: 01-80115-55 The PedFuse Reset pedicle screw implants intended to be used to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine.
Product code: MNI Orthosis, Spinal Pedicle Fixation
Reason for recall: During routine servicing, it was discovered that one 8mmx55mm Reset screw was assembled with an 8mm tulip head and a 9mm screw. The implant should have consisted of an 8mm tulip head and an 8mm screw. A recall was initiated to remove all remaining screws of the same lot from the field to investigate the nonconformity.
Root cause tag: software
FDA root cause: Software design (manufacturing process)
Action: SpineFrontier sent an Voluntary Recall Notification dated November 5,2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. All affected implants are to be returned to SpineFrontier for inspection. SpineFrontier is requiring confirmation that you have received this notice and that you will initiate the immediate return of the implants listed above. IMMEDIATE RESPONSE REQUIRED. Please feel free to contact us at 978-232-3990 Monday through Friday 8:30AM to 5:30PM EST with any questions
Quantity in commerce: 35 Devices
Distribution: US Distribution to VA and TX.
Product codes and lots: Lot/Serial Numbers: 357305-000

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0544-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0544-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-25	2013-12-19

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)