—#208110

Product

CUSA Excel C2600 23KHz Straight Handpiece-Indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft and hard tissue Catalog Number: C2600* *Note: you may see C2600P or C2600SRL on labeling. This notice is applicable for those SKUs as well

FDA product code: LFL — Instrument, Ultrasonic Surgical
Device class: Class U
Medical specialty: Unknown
510(k) numbers: K141674
Affected lot / code info: UDI-DI: 10381780039419 All serial numbers distributed before 12/14/2023 Product manufactured before 11/01/2023. SN: Handpiece manufactured Prior to HAL23XXXXXXIE (represents a product that is manufactured in November 2023): HA indicating the product family Letter indicating the month of manufacture where A = January; B = February, L=November. Two digits e.g 23 indicating the year of manufacture with 23 representing 2023

Why it was recalled

Potential for the CUSA Excel 23KHz Straight Handpiece housing to crack, may result in delay of treatment

Root cause (FDA determination)

Process design

Action the firm took

Integra issued First Notification- Urgent: Voluntary Medical Device Correction on via courier service, facsimile or email about the initial notification between May 29, 2024 and May 31, 2024. Letter states reason for recall, health risk and action to take: B. If your handpiece was manufactured prior to HAL23XXXXXXIE you should take the following actions 1. Inspect the housing for the presence of a crack 2. The Handpiece cracked housing may be visually detected by clinical staff during inspections prior to or postsurgery. If a crack is noted, please remove the handpiece, contact Integra Service and Repair to obtain a Return Material Authorization (RMA), and return to Integra Service and Repair (S&R) for a free housing replacement. The contact information for US S&R is: Integra " 4900 Charlemar Drive, Dock B, Cincinnati, Ohio 45227, Phone Number: 877-444-1114 Option 2, email: integra-service@integralife.com 3. If a crack is not noted, a. Regardless of the service contract status, the housing will be replaced free of charge during your next service. b. **Please note that as per our standard IFU the recommended service frequency should be performed every 50 hours of use or 100 procedures whichever comes first**. 4. Complete the Acknowledgement Form and return to FCA1@integralife.com or FAX to 1-609-750-4220. 5. Keep a copy of the form for your records. Should you have any questions regarding these instructions, please contact Service and Repair: USA: 877-444-1114 Option 2, email: integra-service@integralife.com

Recalling firm

Firm: Integra LifeSciences Corp.
Address: 1100 Campus Rd, Princeton, New Jersey 08540-6650

Distribution

Distribution pattern: Nationwide Foreign: Argentina Australia Bangladesh Bangladesh Belgium Bolivia (Plurinational State of) Brazil Canada Chile China Costa Rica Dominican Republic (the) El Salvador Hong Kong India Indonesia Japan Korea (the Republic of) Malaysia Mexico Mongolia Myanmar Nepal New Zealand Pakistan Panama Peru Philippines (the) Puerto Rico Singapore Sri Lanka Taiwan (Province of China) Thailand Viet Nam

Timeline

Recall initiated: 2024-05-29
Posted by FDA: 2024-06-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #208110. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.