FDAFDA · Food and drugs·Recall number Z-0776-2014
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.
Published January 22, 2014 · Recall initiated: September 24, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Handles and heads may not be compatible.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- SpineFrontier, Inc.
- Distributor
- US Distribution: VA only.
- Lot
- CT128047, CT128048
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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