Z-2167-2024 Class II Ongoing
FDA device recall Z-2167-2024 was initiated by Integra LifeSciences Corp. on May 29, 2024 and is designated Class II. Reason for recall: Potential for the CUSA Excel 23KHz Straight Handpiece housing to crack, may result in delay of treatment The recall status is ongoing. Affected quantity: 2, 652 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 3, 2024
- Initiation Date
- May 29, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2, 652 units
Product Description
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
Reason for Recall
Potential for the CUSA Excel 23KHz Straight Handpiece housing to crack, may result in delay of treatment
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
Code Information
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2167-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026