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U.S. Department of Health and Human Services

Class 2 Device Recall Invue Screws

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  Class 2 Device Recall Invue Screws see related information
Date Initiated by Firm November 20, 2013
Date Posted December 26, 2013
Recall Status1 Open3, Classified
Recall Number Z-0576-2014
Recall Event ID 66914
510(K)Number K121060  
Product Classification Appliance, fixation, spinal intervertebral body - Product Code KWQ
Product Indus Invue Screws: IM71013-XX: Indus Screw04.0mm SelfDrilling.

Used to secure the Invue Anterior Cervical Plate in position.
Code Information Lot/Serial Number: IM71013-01: Lot 0000
Recalling Firm/
SpineFrontier, Inc.
500 Cummings Ctr Ste 3500
Beverly MA 01915-6516
For Additional Information Contact Bill Conlon
Manufacturer Reason
for Recall
Mismarked and unmarked screws
FDA Determined
Cause 2
Packaging process control
Action On 11/20/2013, consignees were notified of the email via letter. Consignees were instructed to return the screws listed in the recall notification letter and return the Recall Acknowledgement form to SpineFrontier via fax or email.
Distribution Nationwide Distribution- including DC and the states of OH, TX, KS, MA, IN, CO, NY, AL, and MI.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = KWQ and Original Applicant = SPINEFRONTIER, INC.