Recall Z-1230-2007

Mentor Texas, Inc · initiated July 27, 2007

Terminated

Product

5mm x 30cm Hollow "Golf" Tip Ultrasonic Aspiration Probe, Model 5620-530, Catalog Number 5620-530.

Codes / lots: Serial numbers: 0028-05, 0035-05, 0069-05, and 0092-05

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.

FDA-determined cause: Other

Action taken

Firm notified consignees by letter on July 27, 2007.

Details

Recall number
Z-1230-2007
Initiated
July 27, 2007
Posted by FDA
September 20, 2007
Terminated
April 4, 2008
Product code
MUU – System, Suction, Lipoplasty
Quantity
4 units
Distribution
Nationwide, including VA, IN, CA, and IL.
Recalling firm
Mentor Texas, Inc, Irving, TX

Official FDA recall record