Recall Z-1207-2007 ยท GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Avazzia, Inc
Avazzia Tennant Biomodulator; Model: BEST AV-1; P/N #TB04303-103; manufactured by Avazzia, Inc., Dallas, TX 75240.
| Date | Sep 1, 2007 (initiated Jun 29, 2007) |
| Status | Terminated |
| Reason | Plastic Cases may crack due to manufacturing by the supplier not meeting specifications |
| 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 | 134 units. |
| Distribution | Nationwide including states of Texas, Pennsylvania, Louisiana, Wyoming, and California |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062641 | BODY-STIM, BIOMODULATOR, BEST-RSI, BEST PRO, MODEL BEST-AV1 Avazzia, Inc., Apr 30, 2007 |