Recall Z-1230-2007 ยท MUU System, Suction, Lipoplasty
Mentor Texas, Inc
5mm x 30cm Hollow "Golf" Tip Ultrasonic Aspiration Probe, Model 5620-530, Catalog Number 5620-530.
| Date | Sep 20, 2007 (initiated Jul 27, 2007) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | Firm notified consignees by letter on July 27, 2007. |
| Quantity | 4 units |
| Distribution | Nationwide, including VA, IN, CA, and IL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041058 | MISONIX INC. LYSONIX 2000/3000 ULTRASONIC SURGICAL ASPIRATOR SYSTEMS Misonix, Inc., May 17, 2004 |