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
Enforcement
- Recall Number
- Z-2167-2024
- Event ID
- 94724
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Integra LifeSciences Corp.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- July 3, 2024
- Initiation Date
- May 29, 2024
- Classification Date
- June 21, 2024
- Address
- 1100 Campus Rd, Princeton, NJ, 08540-6650, United States
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
Potential for the CUSA Excel 23KHz Straight Handpiece housing to crack, may result in delay of treatment
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
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
2, 652 units