Class 2 Device Recall CPlus

• Date Initiated by Firm: October 07, 2013
• Date Posted: January 03, 2014
• Recall Status: Terminated on February 26, 2014
• Recall Number: Z-0627-2014
• Recall Event ID: 67093
• 510(K)Number: K073177
• Product Classification: Intervertebral fusion device with bone graft, cervical - Product Code ODP
• Product: C-Plus" 10mm x 12mm Webless implants Pioneer Surgical's C-Plus " 10mm x 12mm Webless implants are cervical intervertebral fusion devices that are intended to stabilize a cervical spinal segment to promote fusion in order to restrict motion and decrease pain. They are intended for use with supplemental fixation and autograft. These implants are manufactured from PEEK (Polyaryletheretherketone) polymer with tantalum marker pins for radiographic visualization.
• Code Information: part numbers: 30-CW-1012-5, 30-CW-1012-6, 30-CW-1012-7, 30-CW-1012-8, 30-CW-1012-9, 30-CW-1 012-10, 30-CW-1 012-11.
• Recalling Firm/ Manufacturer: RTI Surgical, Inc.; 375 River Park Cir; Marquette MI 49855-1781
• For Additional Information Contact: 906-226-4812
• Manufacturer Reason for Recall: As the result of a recent internal review of regulatory documents, we have determined that the 10 mm x 12 mm Webless C-Plus implants were incorrectly documented as meeting the requirement for labeling as a partial Vertebral Body Replacement Device (VBR). While the use of this device as a partial VBR is unlikely due to the size of the device, use of this device as a partial VBR could result in a s
• FDA Determined Cause: Labeling False and Misleading
• Action: RTI Surgical, Inc. sent an Important Notice letter dated October 8, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed remove fall affected product from their inventory and send back to Customers Service at 375 River Park Circle, Marquette, MI 49855 by October 16, 2013. Customers with questions were instructed to call 906-226-4489. For questions regarding this recall call 906-226-4812.
• Quantity in Commerce: 1906
• Distribution: Nationwide Distribution - USA including FL, MO, NY, CA, MI,and IL.
• 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 = ODP