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U.S. Department of Health and Human Services

Class 2 Device Recall Quantum

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  Class 2 Device Recall Quantum see related information
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/
Pioneer Surgical Technology
375 River Park Cir
Marquette MI 49855-1781
For Additional Information Contact Dan Nelson
Manufacturer Reason
for Recall
Screw may be incorrectly etched as to length.
FDA Determined
Cause 2
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.