Events

Recall of ArenaL Trials (Handles and Heads)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by SpineFrontier, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    66298
  • Event Risk Class
    Class 2
  • Event Number
    Z-0778-2014
  • Event Date Posted
    2014-01-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-08-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124697
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Elevator - Product Code HTE
  • 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: customerservice@spinefrontier.com. Please feel free to contact us at 978-232-3990 Monday through Friday 8:30AM to 5:30PM EST with any questions.

Device

ArenaL Trials (Handles and Heads)
  • Model / Serial
    05171, 2572501, 2572502, 2572503
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Distribution: VA only.
  • 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
  • Manufacturer
    SpineFrontier, Inc.

Manufacturer

SpineFrontier, Inc.
  • Manufacturer Address
    SpineFrontier, Inc., 500 Cummings Ctr Ste 3500, Beverly MA 01915-6516
  • Manufacturer Parent Company (2017)
    SpineFrontier, Inc.
  • Source
    USFDA