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
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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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