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U.S. Department of Health and Human Services

Class 2 Device Recall PedFuse Reset Screw Inserters

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 Class 2 Recall
PedFuse Reset Screw Inserters
see related information
Date Posted December 20, 2013
Recall Status1 Open
Recall Number Z-0555-2014
Recall Event ID 66873
Premarket Notification
510(K) Number
K123164 
Product Classification Orthosis, Spinal Pedicle Fixation - Product Code MNI
Product PedFuse Reset Screw Inserters; PedFuse Screw Inserter 08-9 REset Part# 11-80113 The PedFuse Screw Inserter 05-7 REset, Screw Inserter 05-7 REspond, and Screw Inserter 08-9 REset are used as a screw capture, screw driver, and screw insertion tool in the PedFuse system.
Code Information VM13222- 34489
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
Screw inserters may not mate properly with hex interface of the screws.
FDA Determined
Cause 2
DESIGN: Device Design
Action The firm, SpineFrontier, Inc., sent an "Urgent PedFuse Screw Inserter Voluntary Recall Notification" letter on November 20, 2013 to its consignees/customers. The letter described the product, problem and actions to be taken. The customers were instructed to initiate the immediate return of the recalled products and to complete a recall ACKNOWLEDGEMENT FORM via fax or email to: SpineFrontier, Inc., 500 Cummings Center, Suite 3500, Beverly MA 01915, Attn: Customer Service; Fax: 978-232-3991; email: customerservice@spinefrontier.com. Please feel free to contact at 978-232-3990 Monday thru Friday 8:30AM to 5:30PM Eastern with any questions.
Quantity in Commerce 13
Distribution US Distribution to states of:Texas, New York, Illinois, Ohio, Virginia, Washington D.C., and Florida. .
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 = MNI and Original Applicant = SPINEFRONTIER, INC.
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