Z-2637-2010

Integra CUSA Ultrasonics NXT Ultra Surgical Aspirator System CUSANXT1:Latex Free, Rx only: Integra...

Name: Z-2637-2010 Integra CUSA Ultrasonics NXT Ultra Surgical Aspirator System CUSANXT1:Latex Free, Rx only: Integra...
Creator: Integra LifeSciences Corp.
Published: 2010-07-29
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2010-07-29 / Terminated / root cause: design

FDA source

Integra LifeSciences Corp. began a recall of Integra CUSA Ultrasonics NXT Ultra Surgical Aspirator System CUSANXT1:Latex Free, Rx only: Integra LifeSciences (Ireland) Limited, County Offaly, Ireland... on 2010-07-29. The reason FDA records is "A ground fault malfunction at the rectifier retaining screw may cause the aspiration pump in the CUSA NXT Service module to run at maximum speed, and continue to run until the entire system is turned off. This may...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2637-2010
Status: Terminated
Initiated: 2010-07-29
Posted: 2010-09-30
Terminated: 2012-05-15
Recalling firm: Integra LifeSciences Corporation
Product: Integra CUSA Ultrasonics NXT Ultra Surgical Aspirator System CUSANXT1:Latex Free, Rx only: Integra LifeSciences (Ireland) Limited, County Offaly, Ireland; Distributed by Integra Life Sciences Corporation 311 Enterprise Drive Plainsboro, NJ 08536.
Product code: LFL Instrument, Ultrasonic Surgical
Reason for recall: A ground fault malfunction at the rectifier retaining screw may cause the aspiration pump in the CUSA NXT Service module to run at maximum speed, and continue to run until the entire system is turned off. This may result in excess aspiration that requires medical intervention.
Root cause tag: design
FDA root cause: Device Design
Action: Integra issued Urgent: Product Recall Notification letters dated July 29, 2010 to all customers on July 29, 2010 identifying the affected products, issue prompting the recall, and actions to be taken by the customer. Letters were also forwarded to all Integra Account Reps. Customers were advised to discontinue use of and quarantine the affected service modules. The Surgical Aspirator may be operated without the Service Module, utilizing the hospitals wall aspiration. Company representatives will contact customers to arrange product return and repair of the affected service modules. Customers are to complete and return an enclosed Recall Acknowledgement and Return Form. The firm can be contacted at 609 936-2485.
Quantity in commerce: 26 in US, 8 in Europe and 1 in Asia (both unit types.
Distribution: Worldwide Distribution: USA , including the states of AZ, CA, CO, FL, GA, IA, KY, MN, MO, NV, NY, OH, OR, RI, TX, VA, WI, and the countries of Germany, Hungary, Indonesia, Italy, Netherlands, and Switzerland.
Product codes and lots: Serial numbers: NXT1001-1079, NLB0901901IE, NBL0902101IE, NBL0902501IE, NBA1000501IE, NBC1001501IE, NBC1002001IE, NBC1002301IE, NBC1002901IE, NBE1001301IE, NCE1001901IE, NBF1000701IE, NBD1000101IE.

Product code LFL

K081459UnclassifiedCusa Selector Nxt Ultrasonic Tissue Ablation SystemIntegra Radionics, Inc. / cleared 2008-08-13

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