Z-0141-06

Selector Ultrasonic Integra Ultrasonic Aspirator System, Model 1523211 and 1523215, 24kHz Neuro Short Sterile...

Name: Z-0141-06 Selector Ultrasonic Integra Ultrasonic Aspirator System, Model 1523211 and 1523215, 24kHz Neuro Short Sterile...
Creator: Integra LifeSciences Corp.
Published: 2005-09-13
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2005-09-13 / Terminated / root cause: packaging

FDA source

Integra LifeSciences Corp. began a recall of Selector Ultrasonic Integra Ultrasonic Aspirator System, Model 1523211 and 1523215, 24kHz Neuro Short Sterile Tip Set on 2005-09-13. The reason FDA records is "Integra became aware that certain Model 24kHz Neuro Short Sterile tip Sets were inadvertently packaged with the incorrect 35kHz Neuro Flues". 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-0141-06
Status: Terminated
Initiated: 2005-09-13
Posted: 2005-11-16
Terminated: 2006-10-03
Recalling firm: Integra LifeSciences Corporation
Product: Selector Ultrasonic Integra Ultrasonic Aspirator System, Model 1523211 and 1523215, 24kHz Neuro Short Sterile Tip Set.
Product code: LFL Instrument, Ultrasonic Surgical
Reason for recall: Integra became aware that certain Model 24kHz Neuro Short Sterile tip Sets were inadvertently packaged with the incorrect 35kHz Neuro Flues.
Root cause tag: packaging
FDA root cause: Other
Action: FedEx packages were sent out to their customers 9/13/2005.
Quantity in commerce: 24 (four 1 packs)(four 5 packs)
Distribution: The product is distributed directly to the firm''s sales representatives and direct accounts.
Product codes and lots: Lot 050-779, Model # 1523211; Lot 050-779, Model # 1523215.

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)