CUSA Excel C2600 23KHz Straight Handpiece-Indicated for recall
CUSA Excel C2600 23KHz Straight Handpiece-Indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft and hard…
Why was CUSA Excel C2600 23KHz Straight Handpiece-Indicated for recalled?
Potential for the CUSA Excel 23KHz Straight Handpiece housing to crack, may result in delay of treatment
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- CUSA Excel C2600 23KHz Straight Handpiece-Indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft and hard…
- Recalling firm
- Integra LifeSciences Corp.
- 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 Peru Philippines (the) Puerto Rico Singapore Sri Lanka Taiwan (Province of China) Thailand Viet Nam
- Recall date
- July 3, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)