5mm x 30cm Hollow "Golf" Tip Ultrasonic Aspiration Probe, Model 5620-530, Catalog Number 5620-530.
FDA device recall Z-1230-2007 · posted 2007-09-20 · Terminated
Recall details
- Recalling firm
- Mentor Texas, Inc
- Reason for recall
- Mis-identified and mis-labeled surgical probes were distributed. 5mm x 30cm Hollow "Golf" Tip Ultrasonic Aspiration Probe, Model 5620-530, Catalog Number 5620-530 was shipped, instead of LySonix 5mm x 30cm Hollow Bullet Tip Ultrasonic Probe, Catalog Number 5610-530.
- Action taken
- Firm notified consignees by letter on July 27, 2007.
- Root cause
- Other
- Status
- Terminated
- Product code
- MUU
- Quantity affected
- 4 units
- Distribution
- Nationwide, including VA, IN, CA, and IL.
- Date initiated
- 2007-07-27
- Date posted
- 2007-09-20
- Date terminated
- 2008-04-04
- Location
- Irving, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MISONIX INC. LYSONIX 2000/3000 ULTRASONIC SURGICAL ASPIRATOR SYSTEMS (K041058) | Misonix, Inc. | 2004-05-17 |