FDAClass IIMay 7, 2014

Integra CUSA Excel Disposable Wrench recall

Integra CUSA Excel Disposable Wrench. Catalog Number C5601. The CUSA Excel+ Sterile 23 kHz Torque Wrench is an accessory used with the CUSA Excel+…

Why was Integra CUSA Excel Disposable Wrench recalled?

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 should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Product/Catalog Number C5601; Lot Numbers 1132424, 1132883, 1132884, 1133453, 1133454, 1133455, 1134067, 1134675, 1134873 and 1135014

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+…
Recalling firm
Integra LifeSciences Corp.
Quantity
3,984 devices packaged as 6 devices / box (664 boxes)
Distribution
Worldwide Distribution - USA (nationwide) including the countries of Australia, Canada, and Switzerland.
Recall date
May 7, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls