Z-0431-06

Selector Ultrasonic Integra Ultrasonic Aspirator System, Selector 24kHz Microsurgical Sterile Tip Set

Name: Z-0431-06 Selector Ultrasonic Integra Ultrasonic Aspirator System, Selector 24kHz Microsurgical Sterile Tip Set
Creator: Integra LifeSciences Corp.
Published: 2005-11-28
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2005-11-28 / Terminated / root cause: packaging

FDA source

Integra LifeSciences Corp. began a recall of Selector Ultrasonic Integra Ultrasonic Aspirator System, Selector 24kHz Microsurgical Sterile Tip Set on 2005-11-28. The reason FDA records is "Additional Model 24kHz Tip Sets were inadvertently packaged with the incorrect 35kHz Neuro Flues. (2nd recall, same problem see Z-141-6)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0431-06
Status: Terminated
Initiated: 2005-11-28
Posted: 2006-01-24
Terminated: 2007-02-26
Recalling firm: Integra LifeSciences Corporation
Product: Selector Ultrasonic Integra Ultrasonic Aspirator System, Selector 24kHz Microsurgical Sterile Tip Set.
Product code: LFL Instrument, Ultrasonic Surgical
Reason for recall: Additional Model 24kHz Tip Sets were inadvertently packaged with the incorrect 35kHz Neuro Flues. (2nd recall, same problem see Z-141-6)
Root cause tag: packaging
FDA root cause: Other
Action: Customers were notified of the recall on 11/28/2005 via letter sent by UPS.
Quantity in commerce: 536 units
Distribution: The device is distributed nationwide to hospitals nationwide.
Product codes and lots: Lot 050678 and Lot 050575.

Product code LFL

K021989UnclassifiedSelector Integra Ultrasonic Surgical Aspirator, Model Om 1530000M3Integra Neurosciences / cleared 2002-09-13

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)