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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 Terminated 3 on September 06, 2018
Recall Number Z-0574-2014
Recall Event ID 66914
510(K)Number K121060  
Product Classification Appliance, fixation, spinal intervertebral body - Product Code KWQ
Product Indus Invue Screws: lM71059-XX: Indus Screw 04.2mm SelfDrilling.

Used to secure the Invue Anterior Cervical Plate in position.
Code Information Lot/Serial Number: IM71 059-01: Lot 0000 lM71059-02; IM71059-02: Lot 035M
Recalling Firm/
Manufacturer		 SpineFrontier, Inc.
500 Cummings Ctr Ste 3500
Beverly MA 01915-6516
For Additional Information Contact Bill Conlon
978-232-3990
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.
Quantity in Commerce 922
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 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 = KWQ and Original Applicant = SPINEFRONTIER, INC.
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