Z-0694-2018Class II

Footswitch accessory to the CUSA Clarity Ultrasonic Tissue Ablation System; Catalogue No: C7000

Name: Z-0694-2018 Footswitch accessory to the CUSA Clarity Ultrasonic Tissue Ablation System; Catalogue No: C7000
Creator: Integra LifeSciences Corp.
Published: 2017-09-26
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2017-09-26 / Terminated / root cause: manufacturing process

FDA source

Integra LifeSciences Corp. began a recall of Footswitch accessory to the CUSA Clarity Ultrasonic Tissue Ablation System; Catalogue No: C7000 Product Usage: The footswitch is a component of the CUSA... on 2017-09-26. FDA classified it as Class II and gives the reason as "A faulty footswitch may result in unintended ultrasonic fragmentation activation. There are two scenarios when the failure mode may occur: 1) Ultrasonic fragmentation may be inadvertently activated at start-up or at the...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0694-2018
Classification: Class II
Status: Terminated
Initiated: 2017-09-26
Posted: 2018-02-23
Terminated: 2018-08-14
Recalling firm: Integra LifeSciences Corporation
Product: Footswitch accessory to the CUSA Clarity Ultrasonic Tissue Ablation System; Catalogue No: C7000 Product Usage: The footswitch is a component of the CUSA Clarity Ultrasonic Surgical Aspirator System, which is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft tissue is desirable. The CUSA Clarity Ultrasonic Surgical Aspirator is indicated for use in: Neurosurgery, Plastic and Reconstructive surgery, Orthopedic Surgery, Gynecological Surgery and Thoracic Surgery and the following specific uses are cleared for use in the US only: Gastrointestinal and Affiliated Organ Surgery including removal of benign or malignant tumors or other unwanted tissue, including hepatic parenchyma, in open or laparoscopic procedures, hepatic resection, tumor resection, lobectomy or trisegmentectomy, or removal of tissue during liver allotransplantation and donor hepatectomy Urological surgery including removal of renal parenchyma during nephrectomy or partial nephrectomy General Surgery including removal of benign or malignant tumors or other unwanted soft tissue in open or minimally invasive general surgical procedures Laparoscopic Surgery including removal of hepatic parenchyma in laparoscopic hepatic resection, lobectomy or trisegmentectomy, in laparoscopic donor hepatectomy or laparoscopic cholecystectomy or laparoscopic pancreatic jejunostomy, or pancreatectomy, or laparoscopic appendectomy, laparoscopic colon resection or laparoscopic partial gastrectomy.
Product code: LFL Instrument, Ultrasonic Surgical
Reason for recall: A faulty footswitch may result in unintended ultrasonic fragmentation activation. There are two scenarios when the failure mode may occur: 1) Ultrasonic fragmentation may be inadvertently activated at start-up or at the initial use once the footswitch is connected to the console and after the user primes the system, performs a handpiece test, and enters the Main Screen. 2) Ultrasonic fragmentation may remain activated during surgical use once the foot pedal is disengaged slowly.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Integra I sent an Urgent Voluntary Medical Device Removal Field Safety Notice letter dated September 26, 2017 to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to check the footswitch you received with your purchase of the CUSA Clarity Console, Catalog # C7000for the lot number on the back of the footswitch. Reference pictures are provided on the next page. Compare it to the affected footswitch lot numbers on the next page. If you do have an affected lot number, replace this footswitch with the one that has been provided to you by your sales representative. If you have not yet been provided with the replacement footswitch, please contact your sales representative as soon as possible for a replacement footswitch. 2.Complete the information on the form and either provide it to your sales representative or email or fax as indicated on the form. Keep a copy of the form for your records. For questions regarding the instructions contact SSS E&L at [email protected] or 888-419-0625 option 2.
Quantity in commerce: 155
Distribution: Worldwide Distribution - US Nationwide in 33 states: AL, AR, CA, CO, CT, FL, GA, IA, ID, IL, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NM, NY, OH, OK, OR, PA, TN, TX, VA, WA, WI in the countries of Greece, South Africa, France, Germany, Italy, United Kingdom, Sweden, Netherlands, and Dominican Republic.
Product codes and lots: Lot #1885744; Lot #1923802; Lot #1985221; Lot #2057996; Lot #2109587; Lot #2118507

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0694-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0694-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-02-23

Product code LFL

K161882UnclassifiedCUSA Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation / cleared 2016-10-14

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)