Class 2 Device Recall Songer Spinal Cable System

• Date Initiated by Firm: May 29, 2015
• Date Posted: July 09, 2015
• Recall Status: Terminated on March 17, 2016
• Recall Number: Z-2053-2015
• Recall Event ID: 71474
• Product Classification: Cerclage, fixation - Product Code JDQ
• Product: Songer Spinal Cable System, Single Cable, Crimp, Bar, Stainless Steel, Sterile. The DePuy Spine Cable System can be utilized anywhere monofilament wire has been previously found to be indicated.
• Code Information: Lot Number: PL 193368 Manufacture Date: 09/09/2014 Expiration Date: 09/09/2019
• Recalling Firm/ Manufacturer: RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.); 375 River Park Cir; Marquette MI 49855-1781
• For Additional Information Contact: 906-226-9909
• Manufacturer Reason for Recall: The box end label is incorrectly labeled as Titanium instead of Stainless Steel on one lot of implantable Songer Spinal Cable System, Single Cable, Crimp, Bar, Stainless Steel, Sterile, distributed by DePuy Spine Inc.
• FDA Determined Cause: Labeling Change Control
• Action: On 5/29/15, RTI Surgical sent DePuy/Synthes Spine Inc. with an URGENT: Medical Device Voluntary Recall Notification identifying the recalled product, reason for recall, potential risks, and immediate actions required.
• Quantity in Commerce: 25
• Distribution: Distributed in MA.
• 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.