Class 2 Device Recall Quantum

Date Initiated by Firm	July 29, 2005
Date Posted	October 07, 2005
Recall Status¹	Terminated ³ on October 25, 2005
Recall Number	Z-0020-06
Recall Event ID	32949
Product Classification	Thoracolumbosacral Pedicle Screw System - Product Code NKB
Product	Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 45 mm; Catalog number 10-575-PA-45.
Code Information	Lot 306507.
Recalling Firm/ Manufacturer	Pioneer Surgical Technology 375 River Park Cir Marquette MI 49855-1781
For Additional Information Contact	Dan Nelson 906-226-4489
Manufacturer Reason for Recall	Screw may be incorrectly etched as to length.
FDA Determined Cause ²	Other
Action	Consignees were notified by letter dated 7/29/05 to inspect stocks in storage and at point of use locations hand for correct length and that a firm representative would visit them to pick up any mis-etched product.
Quantity in Commerce	110
Distribution	Nationwide.
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.