Avazzia Med-Sport Massager; Model: BEST AV-1; P/N #MS04182-103; manufactured by Avazzia, Inc., Dallas, TX 75240.
FDA device recall Z-1210-2007 · posted 2007-09-01 · Terminated
Recall details
- Recalling firm
- Avazzia, Inc
- Reason for recall
- Plastic Cases may crack due to manufacturing by the supplier not meeting specifications
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- GZJ
- Quantity affected
- 75 units
- Distribution
- Nationwide including states of Texas, Pennsylvania, Louisiana, Wyoming, and California
- Date initiated
- 2007-06-29
- Date posted
- 2007-09-01
- Date terminated
- 2008-04-04
- Location
- Dallas, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BODY-STIM, BIOMODULATOR, BEST-RSI, BEST PRO, MODEL BEST-AV1 (K062641) | Avazzia, Inc. | 2007-04-30 |