Z-1215-2012

Integra CUSA EXcel Sterile Tips Rx Only Single Use Only

Name: Z-1215-2012 Integra CUSA EXcel Sterile Tips Rx Only Single Use Only
Creator: Integra LifeSciences Corp
Published: 2011-10-14
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2011-10-14 / Terminated

FDA source

Integra LifeSciences Corp began a recall of Integra CUSA EXcel Sterile Tips Rx Only Single Use Only Product Usage: For usage in surgical procedures where fragmentation, emulsification and aspiration of... on 2011-10-14. The reason FDA records is "A small number of non-conforming CUSA Excel 23 KHz Standard Tip and flue (item Number C4601S) were released for distribution that did not meet Integra's in-process requirements for release. It was discovered during...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1215-2012
Status: Terminated
Initiated: 2011-10-14
Posted: 2012-03-15
Terminated: 2012-10-19
Recalling firm: Integra LifeSciences Corporation
Product: Integra CUSA EXcel Sterile Tips Rx Only Single Use Only Product Usage: For usage in surgical procedures where fragmentation, emulsification and aspiration of soft and hard (e.g. bone) tissue is desirable.
Product code: LFL Instrument, Ultrasonic Surgical
Reason for recall: A small number of non-conforming CUSA Excel 23 KHz Standard Tip and flue (item Number C4601S) were released for distribution that did not meet Integra's in-process requirements for release. It was discovered during in-process inspection that the max power reading exceeded the specification of 80 watts, causing the stroke range of the tip to exceed it required range by up a value up to 0.002 inches
FDA root cause: Release of Material/Component prior to receiving test results
Action: Integra sent an Urgent Product Recall Notification letter dated October 14, 2011 to all affected customers via US Mail. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine their inventory, discontinue use, quarantine and return any available affected lot numbers. Customers were instructed to distribute this communication to any customers to whom they have shipped the affected product. Customers were advise to complete the enclosed Recall Acknowledgement and Return Form and return it as soon as possible to Integra Customer Service. For questions contact Integra Customer Service at 609-936-2659.
Quantity in commerce: 24
Distribution: Worldwide Distribution
Product codes and lots: 510K #: K981262 Device Listing #: D001100 Item Number C4601S Lot #: 1112631 Lot #: 1112632 Lot #: 1112633 Lot #: 1112634 Lot #: 1112635 Lot #1113361

Product code LFL

K981262UnclassifiedCusa Excel Ultrasonic Surgical Aspirator SystemValleylab, Inc. / cleared 1998-07-06

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)