Z-0977-2015Class II

lnline Persuader- PedFuse Pedicle Screw System; Part Number: 11-80164

Name: Z-0977-2015 lnline Persuader- PedFuse Pedicle Screw System; Part Number: 11-80164
Creator: SpineFrontier, Inc.
Published: 2014-12-19
License: https://open.fda.gov/license/

SPINEFRONTIER, Inc. dba LESspine Innovations / initiated 2014-12-19 / Terminated / root cause: design

FDA source

SpineFrontier, Inc. began a recall of lnline Persuader- PedFuse Pedicle Screw System; Part Number: 11-80164 on 2014-12-19. FDA classified it as Class II and gives the reason as "A crack may develop in the handle to the Inline Persuader, which may progress if the user continues to use the affected instrument". 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-0977-2015
Classification: Class II
Status: Terminated
Initiated: 2014-12-19
Posted: 2015-01-14
Terminated: 2016-01-11
Recalling firm: SPINEFRONTIER, Inc. dba LESspine Innovations
Product: lnline Persuader- PedFuse Pedicle Screw System; Part Number: 11-80164
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: A crack may develop in the handle to the Inline Persuader, which may progress if the user continues to use the affected instrument.
Root cause tag: design
FDA root cause: Device Design
Action: Spinefrontier sent an Urgent Voluntary Recall Notification letter dated December 16, 2015, to all affected customers. The notice informed customers of the recall and requests that they initiate the immediate return of the parts listed. In addition, SpineFrontier is requiring confirmation via recall acknowledgement form that consignees have received this notice and that they will initiated the immediate return of the parts. Customers can contact SpineFrontier at 978-232-3990 Monday through Friday 8:30AM to 5:30PM EST with any questions.
Quantity in commerce: 4 devices
Distribution: Nationwide Distribution including TX, OH, VA, and Washington, DC.
Product codes and lots: Lot/Serial Numbers: 06440-0000, 06441-0000, AG24

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0977-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0977-2015	Class II	Terminated	Voluntary: Firm initiated	2015-01-21	2015-01-14

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)