Recall Z-0694-2018 ยท LFL Instrument, Ultrasonic Surgical
Integra LifeSciences Corp.
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
| Date | Sep 26, 2017 |
| Status | Terminated |
| 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. |
| 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 provide |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K161882 | CUSA Clarity Ultrasonic Surgical Aspirator System Integra LifeSciences Corporation, Oct 14, 2016 |