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U.S. Department of Health and Human Services

Class 2 Device Recall Invue Screws

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 Class 2 Recall
Invue Screws
see related information
Date Posted December 26, 2013
Recall Status1 Open
Recall Number Z-0575-2014
Recall Event ID 66914
Premarket Notification
510(K) Number
K121060 
Product Classification Appliance, Fixation, Spinal Intervertebral Body - Product Code KWQ
Product Indus Invue Screws: IM71016-XX: 04.5mm, SelfTapping. Used to secure the Invue Anterior Cervical Plate in position.
Code Information Lot/Serial Number: IM71 0 16-01: Lots 0000, 000 1
Recalling Firm/
Manufacturer
SpineFrontier, Inc.
500 Cummings Ctr Ste 3500
Beverly, Massachusetts 01915-6516
For Additional Information Contact Bill Conlon
978-232-3990
Manufacturer Reason
for Recall
Mismarked and unmarked screws
FDA Determined
Cause 2
PRODUCTION CONTROLS: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = KWQ and Original Applicant = SPINEFRONTIER, INC.
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