BEUDAMED
    FDA Recall Terminated

    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

    Recall: Z-0778-2014 · Initiated September 24, 2013

    Recall

    Recall Number
    Z-0778-2014
    Event Number
    66298
    Firm
    SpineFrontier, Inc.
    FEI Number
    3005977257
    Product Code
    HTE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 24, 2013
    Posted
    January 16, 2014
    Terminated
    August 4, 2016
    Address
    500 Cummings Ctr, Ste 3500, Beverly, MA, 01915-6516

    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

    Handles and heads may not be compatible.

    Action

    The firm, SpineFrontier, sent an "URGENT Arena-L Trials Voluntary Recall Notification" letter dated September 24, 2013 sent to its consignee/customer. The letter described the product, problem and actions to be taken. The consignee/customer were instructed to confirm receipt of the notice and contact Customer Service to initiate the immediate return of the listed parts. In addition, consignee/customer were instructed to complete a recall ACKNOWLEDGEMENT FORM and return it to SpineFrontier via fax to: Attention: Customer Service at 978-232-3991 or email to: [email protected]. Please feel free to contact us at 978-232-3990 Monday through Friday 8:30AM to 5:30PM EST with any questions.

    Distribution

    US Distribution: VA only.

    Quantity

    23 devices in total