SpineFrontier, Inc.: Medical Device Recall in 2014 - (Recall #: Z-0777-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: September 24, 2013

Date Posted: January 22, 2014

Recall Number: Z-0777-2014

Event ID: 66298

Reason for Recall:

Handles and heads may not be compatible.

Status: Terminated

Product Quantity: 23 devices in total

Code Information:

2572401, 2572402, 2572405, 05172, 2572403, 2572404

Distribution Pattern:

US Distribution: VA only.

Voluntary or Mandated:

Voluntary: Firm initiated