Date Initiated by Firm |
June 29, 2007 |
Date Posted |
September 01, 2007 |
Recall Status1 |
Terminated 3 on April 04, 2008 |
Recall Number |
Z-1207-2007 |
Recall Event ID |
38308 |
510(K)Number |
K062641
|
Product Classification |
Stimulator, Nerve, Transcutaneous, For Pain Relief - Product Code GZJ
|
Product |
Avazzia Tennant Biomodulator¿; Model: BEST AV-1; P/N #TB04303-103; manufactured by Avazzia, Inc., Dallas, TX 75240. |
Code Information |
Lot Number AC024; The lot number can be found on the serial number label located in the recess of the case where the batteries are installed. If the serial number has "AC024" in the middle, then that device is being recalled. |
Recalling Firm/ Manufacturer |
Avazzia, Inc 13154 Coit Rd Ste 200 Dallas TX 75240-5787
|
For Additional Information Contact |
972-816-7456
|
Manufacturer Reason for Recall |
Plastic Cases may crack due to manufacturing by the supplier not meeting specifications
|
FDA Determined Cause 2 |
Other |
Action |
Firm notified consignees by letter on June 29, 2007 requesting that all affected product be returned to the firm for repair or replacement. The firm further asked for distributors who had shipped affected product to notify receiving patients so they could arrange for repair or replacement. |
Quantity in Commerce |
134 units. |
Distribution |
Nationwide including states of Texas, Pennsylvania, Louisiana, Wyoming, and California |
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.
|
510(K) Database |
510(K)s with Product Code = GZJ and Original Applicant = AVAZZIA, INC.
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