Z-1207-2007

Avazzia Tennant Biomodulator; Model: BEST AV-1; P/N #TB04303-103; manufactured by Avazzia, Inc., Dallas, TX...

Name: Z-1207-2007 Avazzia Tennant Biomodulator; Model: BEST AV-1; P/N #TB04303-103; manufactured by Avazzia, Inc., Dallas, TX...
Creator: Avazzia, Inc
Published: 2007-06-29
License: https://open.fda.gov/license/

Avazzia, Inc / initiated 2007-06-29 / Terminated / root cause: supplier

FDA source

Avazzia, Inc began a recall of Avazzia Tennant Biomodulator; Model: BEST AV-1; P/N #TB04303-103; manufactured by Avazzia, Inc., Dallas, TX 75240 on 2007-06-29. The reason FDA records is "Plastic Cases may crack due to manufacturing by the supplier not meeting specifications". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as supplier.

Recall record

Recall number: Z-1207-2007
Status: Terminated
Initiated: 2007-06-29
Posted: 2007-09-01
Terminated: 2008-04-04
Recalling firm: Avazzia, Inc
Product: Avazzia Tennant Biomodulator; Model: BEST AV-1; P/N #TB04303-103; manufactured by Avazzia, Inc., Dallas, TX 75240.
Product code: GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Reason for recall: Plastic Cases may crack due to manufacturing by the supplier not meeting specifications
Root cause tag: supplier
FDA root cause: 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
Product codes and lots: 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.

Product code GZJ

K062641Class IIBody-Stim, Biomodulator, Best-Rsi, Best Pro, Model Best-Av1Avazzia, Inc. / cleared 2007-04-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)