CUSA Excel C2600 23KHz Straight Handpiece-Indicated for use in surgical procedures where fragmentation, emulsification a
FDA device recall Z-2167-2024 · posted 2024-06-21 · Open, Classified
Recall details
- Recalling firm
- Integra LifeSciences Corp.
- Reason for recall
- Potential for the CUSA Excel 23KHz Straight Handpiece housing to crack, may result in delay of treatment
- Action taken
- 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
- Root cause
- Process design
- Status
- Open, Classified
- Product code
- LFL
- Quantity affected
- 2, 652 units
- Distribution
- 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 Indones
- Date initiated
- 2024-05-29
- Date posted
- 2024-06-21
- Location
- Princeton, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CUSA EXCEL+ ULTRASONIC SURGICAL ASPIRATOR SYSTEM (K141674) | Integra LifeSciences Corporation | 2014-11-06 |