FDA Device recall Z-0694-2018
Footswitch accessory to the CUSA Clarity Ultrasonic Tissue Ablation System
- FDA Device
- Class II
- terminated
- Published 2018-03-07
On 2018-03-07 the FDA classified a Class II recall of Footswitch accessory to the CUSA Clarity Ultrasonic Tissue Ablation System by Integra Lifesciences, citing 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 inadv….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0694-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-09-26 |
| Published | 2018-03-07 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Integra Lifesciences |
| Distribution | US |
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.
Reason
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.
Identifiers
| code_info | Lot #1885744; Lot #1923802; Lot #1985221; Lot #2057996; Lot #2109587; Lot #2118507 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0694-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.