Z-0624-2014Class II

PedFuse Bone Probe; Part: SI81008 spinal pedicle fixation

Name: Z-0624-2014 PedFuse Bone Probe; Part: SI81008 spinal pedicle fixation
Creator: SpineFrontier, Inc.
Published: 2013-09-11
License: https://open.fda.gov/license/

SPINEFRONTIER, Inc. dba LESspine Innovations / initiated 2013-09-11 / Terminated / root cause: manufacturing process

FDA source

SpineFrontier, Inc. began a recall of PedFuse Bone Probe; Part: SI81008 spinal pedicle fixation on 2013-09-11. FDA classified it as Class II and gives the reason as "Bone Probes used to create a pathway in pedicle bone were manufactured and marked to incorrect specifications". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0624-2014
Classification: Class II
Status: Terminated
Initiated: 2013-09-11
Posted: 2014-01-03
Terminated: 2014-10-08
Recalling firm: SPINEFRONTIER, Inc. dba LESspine Innovations
Product: PedFuse Bone Probe; Part: SI81008 spinal pedicle fixation.
Product code: HXB Probe
Reason for recall: Bone Probes used to create a pathway in pedicle bone were manufactured and marked to incorrect specifications.
Root cause tag: manufacturing process
FDA root cause: Process change control
Action: On 9/13/2013, consignees were notified of the recall via email. They were asked to return the recalled product and complete and return the recall acknowledgement form via email or fax.
Quantity in commerce: 13 devices
Distribution: US Distribution: including states of: TX and VA.
Product codes and lots: Lot: 012212-001

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0624-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0624-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-15	2014-01-03

Product code HXB

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)