Device 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.
Z-0777-2014
Product summary
- Event
- Event 66298
- Status
- Terminated
- Classification
- Class II
- Quantity
- 23 devices in total
- Official record key
device-enforcement:Z-0777-2014
Official wording
Reason: Handles and heads may not be compatible.
Code information: 2572401, 2572402, 2572405, 05172, 2572403, 2572404
Distribution pattern: US Distribution: VA only.
Derived failure modes
-
Unknown
Handles and heads may not be compatible.