Integra CUSA Excel Disposable Wrench Recalled for Incorrect Assembly
Integra LifeSciences is recalling CUSA Excel Disposable Wrenches because some units were incorrectly assembled with the wrong hex wrench insert.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves incorrect assembly of a surgical accessory without reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
Integra LifeSciences Corp. is recalling the CUSA Excel Disposable Wrench, Catalog Number C5601. The recall involves 3,984 devices packaged as 6 devices per box, totaling 664 boxes. The product is an accessory used with the CUSA Excel+ System ultrasonic surgical instrument to secure the CUSA tip to the handpiece in the sterile field.
The recall was initiated because some 23 kHz Torque Wrenches were incorrectly assembled and contained a 36 kHz Hex Wrench Insert instead of the required 23 kHz Hex Wrench Insert. The affected lot numbers are 1132424, 1132883, 1132884, 1133453, 1133454, 1133455, 1134067, 1134675, 1134873, and 1135014.
The devices were distributed worldwide, including the United States (nationwide), Australia, Canada, and Switzerland. Healthcare facilities and users should check their inventory for the specific catalog and lot numbers listed and stop using the affected devices.
The recalled product
- 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 steril
- Manufacturer
- Integra LifeSciences Corp.
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- Product/Catalog Number C5601
- Lot Numbers 1132424
- 1132883
- 1132884
- 1133453
- 1133454
- 1133455
- 1134067
- 1134675
- 1134873 and 1135014
Distribution
Distributed nationwide across the United States.
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