Class 2 Device Recall Streamline OCT OccipitoCervicoThoracic System, Crosslink Counter Torque Sleeve

• Date Initiated by Firm: April 22, 2016
• Date Posted: May 26, 2016
• Recall Status: Terminated on February 08, 2017
• Recall Number: Z-1829-2016
• Recall Event ID: 74031
• 510(K)Number: K150254
• Product Classification: Appliance, fixation, spinal interlaminal - Product Code KWP
• Product: Streamline OCT Occipito-Cervico-Thoracic System, Crosslink Counter Torque Sleeve. Spinal fixation device instrument.
• Code Information: Streamline OCT Occipito-Cervico-Thoracic System, Crosslink Counter Torque Sleeve; Lot Number: 170684; Part Number: 26-COUNTER-T-XLINK
• FEI Number: 1000115331
• Recalling Firm/ Manufacturer: RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.); 375 River Park Cir; Marquette MI 49855-1781
• For Additional Information Contact: Dan Nelson; 906-226-4489
• Manufacturer Reason for Recall: Potential for a product defect where the cannula may be obstructed. This obstruction could prevent a driver from going through, which increases the potential for the driver to slip, resulting in possible patient injury.
• FDA Determined Cause: Process design
• Action: RTI sent an Urgent Voluntary Product Notification dated April 22, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. RTI Surgical is conducting a voluntary recall of the Streamline OCT Occipito-Cervico-Thoracic System, Crosslink Counter Torque Sleeve due to the potential for a product defect where the cannula may be obstructed. This obstruction could prevent a driver from going through, which increases the potential for the driver to slip resulting in possible patient injury. For further questions, please call (906) 226-4489.
• Quantity in Commerce: 17 devices
• Distribution: US nationwide distribution in CA, FL, IN, MI, MO, NC, NY, and TX.
• 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