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U.S. Department of Health and Human Services

Enforcement Report - Week of January 22, 2014

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Product Detail

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.
Recall Number Z-0776-2014
Classification Class II
Code Info CT128047, CT128048, 2572401, 2572402, 2572405, 05172, 2572403, 2572404, 05171, 2572501, 2572502, 2572503
Product Distributed Qty 23 devices in total
Reason For Recall Handles and heads may not be compatible.

Event Detail

Event Id 66298
Product Type Devices
Status Ongoing
Recalling Firm SpineFrontier, Inc.
City Beverly
State MA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-09-24
Initial Firm Notification of Consignee or Public E-Mail
Distribution Pattern US Distribution: VA only.
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