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U.S. Department of Health and Human Services

Class 2 Device Recall Footswitch accessory

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  Class 2 Device Recall Footswitch accessory see related information
Date Initiated by Firm September 26, 2017
Create Date February 23, 2018
Recall Status1 Terminated 3 on August 14, 2018
Recall Number Z-0694-2018
Recall Event ID 79171
510(K)Number K161882  
Product Classification Instrument, ultrasonic surgical - Product Code LFL
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.
Code Information Lot #1885744; Lot #1923802; Lot #1985221; Lot #2057996; Lot #2109587; Lot #2118507
Recalling Firm/
Manufacturer		 Integra LifeSciences Corp.
311 Enterprise Dr
Plainsboro NJ 08536-3344
For Additional Information Contact Dr. Patricia Kihn
717-309-3966
Manufacturer 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.
FDA Determined
Cause 2		 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 sssel@integralife.com 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LFL and Original Applicant = INTEGRA LIFESCIENCES CORPORATION
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