Class 2 Device Recall Pioneer Quantum Spinal Rod System

• Date Initiated by Firm: October 10, 2007
• Date Posted: November 27, 2007
• Recall Status: Terminated on March 31, 2008
• Recall Number: Z-0291-2008
• Recall Event ID: 45526
• Product Classification: Yoke Manipulator - Product Code HWR
• Product: Pioneer Quantum Spinal Rod System, MIS Yoke Manipulator, Long Slot, non-sterile; Cat # 51-YOKEMAN-L, Pioneer Surgical Technology, Marquette, MI 49855
• Code Information: Lot 013886.
• FEI Number: 1000115331
• Recalling Firm/ Manufacturer: Pioneer Surgical Technology; 375 River Park Cir; Marquette MI 49855-1781
• For Additional Information Contact: 906-226-9909
• Manufacturer Reason for Recall: The pins may come out of the instrument and, if this happens, they could fall into/remain in the patient.
• FDA Determined Cause: Component change control
• Action: Consignees were notified via a Product Recall letter dated 10/10/07 to remove these instruments from their instrument cases and to return them to the firm.
• Quantity in Commerce: 38
• Distribution: Nationwide: including states of California, Florida, Michigan and North Carolina.
• 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.