Device 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.
Z-1522-2014
Product summary
- Event
- Event 67902
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3,984 devices packaged as 6 devices / box (664 boxes)
- Official record key
device-enforcement:Z-1522-2014
Official wording
Reason: Some 23 kHz Torque Wrenches were incorrectly assembled and contained a 36 kHz Hex Wrench Insert instead of the 23 kHz Hex Wrench Insert.
Code information: Product/Catalog Number C5601; Lot Numbers 1132424, 1132883, 1132884, 1133453, 1133454, 1133455, 1134067, 1134675, 1134873 and 1135014
Distribution pattern: Worldwide Distribution - USA (nationwide) including the countries of Australia, Canada, and Switzerland.
Derived failure modes
-
Unknown
Some 23 kHz Torque Wrenches were incorrectly assembled and contained a 36 kHz Hex Wrench Insert instead of the 23 kHz Hex Wrench Insert.