Z-0777-2014Class II

Arena-L 35x26 Trial Head I 10 Lordotic; Part: 11-81004-08, 11-81004-10, 11-81004-12, 11-81004-14, 11-81004-16...

Name: Z-0777-2014 Arena-L 35x26 Trial Head I 10 Lordotic; Part: 11-81004-08, 11-81004-10, 11-81004-12, 11-81004-14, 11-81004-16...
Creator: SpineFrontier, Inc.
Published: 2013-09-24
License: https://open.fda.gov/license/

SPINEFRONTIER, Inc. dba LESspine Innovations / initiated 2013-09-24 / Terminated

FDA source

SpineFrontier, Inc. began a recall of Arena-L 35x26 Trial Head I 10 Lordotic; Part: 11-81004-08, 11-81004-10, 11-81004-12, 11-81004-14, 11-81004-16 The trial heads are smooth plates that mimic the... on 2013-09-24. FDA classified it as Class II and gives the reason as "Handles and heads may not be compatible". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0777-2014
Classification: Class II
Status: Terminated
Initiated: 2013-09-24
Posted: 2014-01-16
Terminated: 2016-08-04
Recalling firm: SPINEFRONTIER, Inc. dba LESspine Innovations
Product: Arena-L 35x26 Trial Head I 10 Lordotic; Part: 11-81004-08, 11-81004-10, 11-81004-12, 11-81004-14, 11-81004-16 The trial heads are smooth plates that mimic the footprint of the implant, manufactured from 17-4 Stainless Steel into 35X26mm (11-81004-XX) and 38X28mm (11-81012-XX) varieties, each with multiple height configurations. The Trial Heads are intended to attach tot he Trial Handle (11-81002) and to be inserted into the intervertebral disc space. The Trial Handle consists of a knurled handle and cylindrical shaft with an M4 threads interface at the distal end; 17-4 Stainless steel is used as the material for the handles. The Trial Heads distract the disc space to the surgeon's desired height to gauge which size implant should be utilized to complete the Anterior Lumbar Interbody Fusion Procedure.
Product code: HTE Elevator
Reason for recall: Handles and heads may not be compatible.
FDA root cause: Other
Action: The firm, SpineFrontier, sent an "URGENT Arena-L Trials Voluntary Recall Notification" letter dated September 24, 2013 sent to its consignee/customer. The letter described the product, problem and actions to be taken. The consignee/customer were instructed to confirm receipt of the notice and contact Customer Service to initiate the immediate return of the listed parts. In addition, consignee/customer were instructed to complete a recall ACKNOWLEDGEMENT FORM and return it to SpineFrontier via fax to: Attention: Customer Service at 978-232-3991 or email to: [email protected]. 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: 23 devices in total
Distribution: US Distribution: VA only.
Product codes and lots: 2572401, 2572402, 2572405, 05172, 2572403, 2572404

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0777-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0776-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-22	2014-01-16
Z-0777-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-22	2014-01-16
Z-0778-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-22	2014-01-16

Product code HTE

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)