Z-0776-2014 Class II Terminated
FDA device recall Z-0776-2014 was initiated by SpineFrontier, Inc. on Sep 24, 2013 and is designated Class II. Reason for recall: Handles and heads may not be compatible. The recall status is terminated (terminated Aug 4, 2016). Affected quantity: 23 devices in total.
Recall details
- Product Type
- Devices
- Report Date
- Jan 22, 2014
- Initiation Date
- Sep 24, 2013
- Termination Date
- Aug 4, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 23 devices in total
Product description
Arena-L Trial Handle; Part: 11-81002 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.
Reason for recall
Handles and heads may not be compatible.
Distribution pattern
US Distribution: VA only.
Code information
CT128047, CT128048
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0776-2014
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026