FDA-Device2014-05-07Class II
Integra CUSA Excel Disposable Wrench. Catalog Number C5601. The CUSA Excel+ Sterile 23 kHz Torque Wrench is an accessory used with the CUSA Excel+ System ultrasonic surgical instrument. The torque wrench is used to properly secure the CUSA tip to the CUSA handpiece in the sterile field.
Integra LifeSciences Corp.
Hazard
Some 23 kHz Torque Wrenches were incorrectly assembled and contained a 36 kHz Hex Wrench Insert instead of the 23 kHz Hex Wrench Insert.
Sold states
Worldwide Distribution - USA (nationwide) including the countries of Australia, Canada, and Switzerland.
Affected count
3,984 devices packaged as 6 devices / box (664 boxes)
Manufactured in
311 Enterprise Dr, Plainsboro, NJ, United States
Products
Integra CUSA Excel Disposable Wrench. Catalog Number C5601. The CUSA Excel+ Sterile 23 kHz Torque Wrench is an accessory used with the CUSA Excel+ System ultrasonic surgical instrument. The torque wrench is used to properly secure the CUSA tip to the CUSA handpiece in the sterile field.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1522-2014Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief