CUSA Excel C2600 23KHz Straight Handpiece-Indicated for use in surgical procedures where fragmentation, emulsification a
Summary
The FDA issued a Class II for CUSA Excel C2600 23KHz Straight Handpiece-Indicated for use in surgical procedur by Integra LifeSciences Corp.. Reason: Potential for the CUSA Excel 23KHz Straight Handpiece housing to crack, may result in delay of treatment.
Details
Source
Device Recall
External ID
Z-2167-2024
Action Date
2024-07-03
Status
Ongoing
Category
device
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
Lot/Code Info: 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
Quantity Affected: 2, 652 units
Reason for Recall
Potential for the CUSA Excel 23KHz Straight Handpiece housing to crack, may result in delay of treatment
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
Type: Voluntary: Firm initiated
Recall Initiated: 2024-05-29
Company
Princeton, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 167 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Integra LifeSciences Corp. has 64 FDA actions in our database, including 64 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Integra LifeSciences Corp.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Integra LifeSciences Corp. have FDA actions?
Integra LifeSciences Corp. has 64 FDA actions in our database, including 64 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2167-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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