FDAFDA · Food and drugs·Recall number Z-1522-2014
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.
Published May 7, 2014 · Recall initiated: March 10, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Integra LifeSciences Corp.
- Distributor
- Worldwide Distribution - USA (nationwide) including the countries of Australia, Canada, and Switzerland.
- Lot
- Product/Catalog Number C5601; Lot Numbers 1132424, 1132883, 1132884, 1133453, 1133454, 1133455, 1134067, 1134675, 1134873 and 1135014
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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