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U.S. Department of Health and Human Services

Class 2 Device Recall SpineFrontier PedFuse Pedicle Screw System

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  Class 2 Device Recall SpineFrontier PedFuse Pedicle Screw System see related information
Date Initiated by Firm December 19, 2014
Date Posted January 14, 2015
Recall Status1 Terminated 3 on January 11, 2016
Recall Number Z-0977-2015
Recall Event ID 70065
Product Classification Orthopedic manual surgical instrument - Product Code LXH
Product lnline Persuader- PedFuse Pedicle Screw System; Part Number: 11-80164
Code Information Lot/Serial Numbers: 06440-0000, 06441-0000, AG24
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		 A crack may develop in the handle to the Inline Persuader, which may progress if the user continues to use the affected instrument.
FDA Determined
Cause 2		 Device Design
Action Spinefrontier sent an Urgent Voluntary Recall Notification letter dated December 16, 2015, to all affected customers. The notice informed customers of the recall and requests that they initiate the immediate return of the parts listed. In addition, SpineFrontier is requiring confirmation via recall acknowledgement form that consignees have received this notice and that they will initiated the immediate return of the parts. Customers can contact SpineFrontier at 978-232-3990 Monday through Friday 8:30AM to 5:30PM EST with any questions.
Quantity in Commerce 4 devices
Distribution Nationwide Distribution including TX, OH, VA, and Washington, DC.
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.
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