Z-1230-2007

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

Name: Z-1230-2007 5mm x 30cm Hollow "Golf" Tip Ultrasonic Aspiration Probe, Model 5620-530, Catalog Number 5620-530
Creator: Mentor Texas, Inc
Published: 2007-07-27
License: https://open.fda.gov/license/

Mentor / initiated 2007-07-27 / Terminated / root cause: labeling and UDI

FDA source

Mentor Texas, Inc began a recall of 5mm x 30cm Hollow "Golf" Tip Ultrasonic Aspiration Probe, Model 5620-530, Catalog Number 5620-530 on 2007-07-27. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1230-2007
Status: Terminated
Initiated: 2007-07-27
Posted: 2007-09-20
Terminated: 2008-04-04
Recalling firm: Mentor
Product: 5mm x 30cm Hollow "Golf" Tip Ultrasonic Aspiration Probe, Model 5620-530, Catalog Number 5620-530.
Product code: MUU System, Suction, Lipoplasty
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.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Firm notified consignees by letter on July 27, 2007.
Quantity in commerce: 4 units
Distribution: Nationwide, including VA, IN, CA, and IL.
Product codes and lots: Serial numbers: 0028-05, 0035-05, 0069-05, and 0092-05

Product code MUU

K041058Class IIMisonix Inc. Lysonix 2000/3000 Ultrasonic Surgical Aspirator SystemsMisonix, Inc. / cleared 2004-05-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)