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Class 2 Device Recall Pioneer Quantum Spinal Rod System |
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Date Initiated by Firm |
October 10, 2007 |
Date Posted |
November 27, 2007 |
Recall Status1 |
Terminated 3 on March 31, 2008 |
Recall Number |
Z-0291-2008 |
Recall Event ID |
45526 |
Product Classification |
Yoke Manipulator - Product Code HWR
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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. |
Recalling Firm/ Manufacturer |
Pioneer Surgical Technology 375 River Park Cir Marquette MI 49855-1781
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For Additional Information Contact |
906-226-9909
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Manufacturer Reason for Recall |
The pins may come out of the instrument and, if this happens, they could fall into/remain in the patient.
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FDA Determined Cause 2 |
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
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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.
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