Home / Recalls / Medical Devices
Integra LifeSciences Corp. recalls Integra CUSA Excel Disposable Wrench. Catalog Number C5601. The CUSA Excel+ Sterile 23 kHz Torque Wrench is an accessor
Recalled May 7, 2014 · FDA recall Z-1522-2014 · Integra LifeSciences
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. · FDA Class II
Units
3,984 devices packaged as 6 devices / box (664 boxes)
Sold at
Worldwide Distribution - USA (nationwide) including the countries of Australia, Canada, and Switzerland.
Description
Some 23 kHz Torque Wrenches were incorrectly assembled and contained a 36 kHz Hex Wrench Insert instead of the 23 kHz Hex Wrench Insert.
Product
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.
Manufacturer(s)
Integra LifeSciences Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →