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Class 2 Device Recall NeuroTherm |
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Date Initiated by Firm |
July 28, 2008 |
Date Posted |
January 13, 2009 |
Recall Status1 |
Terminated 3 on September 24, 2009 |
Recall Number |
Z-0838-2009 |
Recall Event ID |
50136 |
510(K)Number |
K011387
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Product Classification |
Radiofrequency lesion probe - Product Code GXI
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Product |
NeuroTherm Simplicity III RF Electrode Model Number: RFDE-SI The lesioning of neural tissue. |
Code Information |
Lot numbers: 080630- 1 B and 080630- 1 C Exp. June 2011 |
Recalling Firm/ Manufacturer |
Neurotherm, Inc. 2 De Bush Ave Unit A2 Middleton MA 01949-1679
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For Additional Information Contact |
SAME 978-777-3916
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Manufacturer Reason for Recall |
Distal tip may detach from the probe
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FDA Determined Cause 2 |
Labeling design |
Action |
NeuroTherrn sales representatives were notified
telephonically or through e-mail. End users were notified through visits by NeuroTherm sales representatives on 7/28/08 and 8/15/08. For questions, please contact NeuroTherm, Inc. at 1-978-777-3916. |
Quantity in Commerce |
71 units |
Distribution |
CO, FL, IL, OH, TN, TX , VA, and WY
Foreign: Australia, China, and UK, |
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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510(K) Database |
510(K)s with Product Code = GXI and Original Applicant = EUROLINK LLC.
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