Z-0778-2014 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- January 22, 2014
- Initiation Date
- September 24, 2013
- Termination Date
- August 4, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 23 devices in total
Product Description
Arena-L 38x28Trial Head I 10¿ Lordotic; Part: 11-81012-08, 11-81012-10, 11-81012-12, 11-81012-14 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
05171, 2572501, 2572502, 2572503