Date Initiated by Firm | July 18, 2008 |
Date Posted | April 19, 2012 |
Recall Status1 |
Terminated 3 on April 19, 2012 |
Recall Number | Z-1440-2012 |
Recall Event ID |
49410 |
Product Classification |
Stimulator, nerve, transcutaneous, for pain relief - Product Code GZJ
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Product | Synaptic 3600 and 3800 with Cranial Electrical Stimulation manufactured by Synaptic USA, Aurora, CO.
Transcutaneous nerve stimulation for pain relief and other medical treatment uses. |
Code Information |
Synaptic 3600 and 3800 with cranial electrical stimulation, all codes and lots. |
Recalling Firm/ Manufacturer |
Synaptic Corp 3176 S Peoria Ct Ste 110 Aurora CO 80014-3127
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For Additional Information Contact | Chris Zueger 303-696-6325 Ext. 1 |
Manufacturer Reason for Recall | Device was distributed without marketing approval. |
FDA Determined Cause 2 | PMA |
Action | Synaptic Corp, sent a Urgent Medical Device Recall letter dated July 14th, 2008, to all affected customers. The letter identified the product the problem and the action to be taken by the customer.
The customer was instructed to return your 3600 and or 3800 devices so that the cranial stimulator can be removed and destroyed.
Please call 1-800-685-7246 to schedule pick up of your device..
Complete the enclosed Confirmation Form and return it ( postage paid) to Synaptic Corp. It is important that you return the attached response confirmation form even if you do not have the (CES) module in your model.
Should you have any questions about this recall please call 1-800-685-7246 ext. 101. |
Quantity in Commerce | 59 units |
Distribution | Worldwide Distribution -- USA (nationwide) and the country 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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