PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: July 3, 2024 Initiated: May 29, 2024 #Z-2167-2024

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

Details

Units Affected
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
Location
Princeton, NJ

Frequently Asked Questions

What product was recalled?
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. Recalled by Integra LifeSciences Corp.. Units affected: 2, 652 units.
Why was this product recalled?
Potential for the CUSA Excel 23KHz Straight Handpiece housing to crack, may result in delay of treatment
Which agency issued this recall?
This recall was issued by the FDA Devices on July 3, 2024. Severity: Moderate. Recall number: Z-2167-2024.