Class 2 Device Recall STREAMLINE CT CERVICOTHORACIC SYSTEM

• Date Initiated by Firm: September 10, 2012
• Date Posted: September 03, 2014
• Recall Status: Terminated on September 30, 2014
• Recall Number: Z-2573-2014
• Recall Event ID: 69033
• 510(K)Number: K112757
• Product Classification: Appliance, fixation, spinal interlaminal - Product Code KWP
• Product: STREAMLINE CT CERVICO-THORACIC SYSTEM; SET SCREW REF 26-SETSCREW NON-STERILE, SINGLE USE, RX ONLY
• Code Information: Lot numbers: 104875, 104876, 104877, 104878, 104879, 104880, 104881 , 117030,117031 , 121947, 124260.
• Recalling Firm/ Manufacturer: PIONEER SURGICAL TECHNOLOGY, INC.; 375 River Park Cir; Marquette MI 49855-1781
• For Additional Information Contact: 906-226-4812
• Manufacturer Reason for Recall: Some set screw thread profiles were found not to be within specifications.
• FDA Determined Cause: Nonconforming Material/Component
• Action: The recall took place at the distributor/sales representative level. Communication was done through phone and email notifications on 9/10/2012. All affected set screws were to be traded out through a scheduled process. This was coordinated through Pioneer Surgical's customer service. Product was scrapped and no reconditioning took place. All affected set screws were swapped out.
• Quantity in Commerce: 11 sets
• Distribution: Distributed in the states of NC, NH, NY, CA, MI, IL, and FL.
• 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 = KWP