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U.S. Department of Health and Human Services

Class 2 Device Recall Orthofix

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  Class 2 Device Recall Orthofix see related information
Date Initiated by Firm November 26, 2013
Date Posted January 28, 2014
Recall Status1 Terminated 3 on December 09, 2014
Recall Number Z-0855-2014
Recall Event ID 66969
510(K)Number K081684  
Product Classification Appliance, fixation, spinal interlaminal - Product Code KWP
Product Orthofix Firebird Spinal Fixation System Instrumentation Modular Screw Driver,

Product Usage: The Modular Screw Driver is used for inserting a modular bone screw into the pedicle during a spinal fixation procedure. It is a reusable instrument.
Code Information Production Identification Numbers: Part Number 52-1332, All Lot Numbers.
Recalling Firm/
Orthofix, Inc.
3451 Plano Pkwy
Lewisville TX 75056-9453
For Additional Information Contact Christopher Hack
Manufacturer Reason
for Recall
Orthofix received 6 complaints which resulted in a reportable events due to extended surgical times greater than 30 minutes for the Modular Screw Driver (PN 52-1332). The complaints alleged that the screw driver's collet would malfunction resulting in the surgeon being unable to use the Modular Screw Driver to effectively place Modular Screws, which may result in a delay of surgery.
FDA Determined
Cause 2
Nonconforming Material/Component
Action Orthofix sent an Urgent Medical Device Recall Notification letter dated November 26, 2013 by certified mail to distributors. The letter identified the affected product, problem and actions to be taken. The letter instructed distributors to immediately cease any further distribution, return affected products to Orthofix at no cost and complete the attached reply form. For questions contact your local Orthofix representative.
Quantity in Commerce 443
Distribution Worldwide Distribution - US Nationwide including (Puerto Rico) and the countries of: Spain, Germany, Australia, Peru, Mexico, Colombia, South Africa, and Israel.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KWP and Original Applicant = BLACKSTONE MEDICAL, INC.