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U.S. Department of Health and Human Services

Class 2 Device Recall PedFuse Reset Screw

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 Class 2 Recall
PedFuse Reset Screw
see related information
Date Posted December 19, 2013
Recall Status1 Open
Recall Number Z-0544-2014
Recall Event ID 66698
Premarket Notification
510(K) Number
K123164 
Product Classification Orthosis, Spinal Pedicle Fixation - Product Code MNI
Product PedFuse Reset Screw; Model: 01-80115-55 The PedFuse Reset pedicle screw implants intended to be used to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine.
Code Information Lot/Serial Numbers: 357305-000
Recalling Firm/
Manufacturer
SpineFrontier, Inc.
500 Cummings Ctr Ste 3500
Beverly, Massachusetts 01915-6516
For Additional Information Contact Helen Moon
978-232-3990
Manufacturer Reason
for Recall
During routine servicing, it was discovered that one 8mmx55mm Reset screw was assembled with an 8mm tulip head and a 9mm screw. The implant should have consisted of an 8mm tulip head and an 8mm screw. A recall was initiated to remove all remaining screws of the same lot from the field to investigate the nonconformity.
FDA Determined
Cause 2
DESIGN: Software Design (Manufacturing Process)
Action SpineFrontier sent an Voluntary Recall Notification dated November 5,2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. All affected implants are to be returned to SpineFrontier for inspection. SpineFrontier is requiring confirmation that you have received this notice and that you will initiate the immediate return of the implants listed above. IMMEDIATE RESPONSE REQUIRED. Please feel free to contact us at 978-232-3990 Monday through Friday 8:30AM to 5:30PM EST with any questions.
Quantity in Commerce 35 Devices
Distribution US Distribution to VA and TX.
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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