FDA recall Z-2167-2024

Integra LifeSciences Corp. · Class II · device

Product

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

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

Key facts

Status
Ongoing
Initiation date
2024-05-29
Report date
2024-07-03
Voluntary/Mandated
Voluntary: Firm initiated
Location
Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2167-2024