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U.S. Department of Health and Human Services

Class 2 Device Recall Synaptic

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  Class 2 Device Recall Synaptic see related information
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
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
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
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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