Z-2167-2024Class II

CUSA Excel C2600 23KHz Straight Handpiece-Indicated for use in surgical procedures where fragmentation...

Name: Z-2167-2024 CUSA Excel C2600 23KHz Straight Handpiece-Indicated for use in surgical procedures where fragmentation...
Creator: Integra LifeSciences Corp.
Published: 2024-05-29
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2024-05-29 / Open, Classified / root cause: manufacturing process

FDA source

Integra LifeSciences Corp. began a recall of CUSA Excel C2600 23KHz Straight Handpiece-Indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft and hard tissue... on 2024-05-29. FDA classified it as Class II and gives the reason as "Potential for the CUSA Excel 23KHz Straight Handpiece housing to crack, may result in delay of treatment". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2167-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-05-29
Posted: 2024-06-21
Recalling firm: Integra LifeSciences Corporation
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
Product code: LFL Instrument, Ultrasonic Surgical
Reason for recall: Potential for the CUSA Excel 23KHz Straight Handpiece housing to crack, may result in delay of treatment
Root cause tag: manufacturing process
FDA 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 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: [email protected] 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 [email protected] 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: [email protected]
Quantity in commerce: 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 Peru Philippines (the) Puerto Rico Singapore Sri Lanka Taiwan (Province of China) Thailand Viet Nam
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2167-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2167-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-03	2024-06-21

Product code LFL

K141674UnclassifiedCusa Excel+ Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation / cleared 2014-11-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)