Recall Z-2167-2024 ยท LFL Instrument, Ultrasonic Surgical
Integra LifeSciences Corp.
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
| Date | Jun 21, 2024 (initiated May 29, 2024) |
| Status | Open, Classified |
| Reason | Potential for the CUSA Excel 23KHz Straight Handpiece housing to crack, may result in delay of treatment |
| Root cause | Process design |
| Action | 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 Servic |
| Quantity | 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 Indonesia Japan Korea (the Republic of) Malaysia Mexico Mongolia Myanmar Nepal New Zealand Pakistan Panama |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141674 | CUSA EXCEL+ ULTRASONIC SURGICAL ASPIRATOR SYSTEM Integra LifeSciences Corporation, Nov 6, 2014 |