Z-1522-2014Class II

Integra CUSA Excel Disposable Wrench. Catalog Number C5601. The CUSA Excel+ Sterile 23 kHz Torque Wrench is...

Name: Z-1522-2014 Integra CUSA Excel Disposable Wrench. Catalog Number C5601. The CUSA Excel+ Sterile 23 kHz Torque Wrench is...
Creator: Integra LifeSciences Corp.
Published: 2014-03-10
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2014-03-10 / Terminated

FDA source

Integra LifeSciences Corp. began a recall of 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... on 2014-03-10. FDA classified it as Class II and gives the reason as "Some 23 kHz Torque Wrenches were incorrectly assembled and contained a 36 kHz Hex Wrench Insert instead of the 23 kHz Hex Wrench Insert". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1522-2014
Classification: Class II
Status: Terminated
Initiated: 2014-03-10
Posted: 2014-04-29
Terminated: 2015-02-13
Recalling firm: Integra LifeSciences Corporation
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.
Product code: LFL Instrument, Ultrasonic Surgical
Reason for recall: 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 root cause: Under Investigation by firm
Action: Integra sent an Urgent: Voluntary Medical Device Recall letter dated March 10, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The written notifications were delivered to US consignees by traceable courier service and non-US consignees by traceable email or facsimile. Integra is asking that you do the following: 1. Review your unused inventory of 23 kHz CUSA Sterile Torque Wrenches and determine if they are on the affected lot number list on the next page and if they are still in the box. 2. Complete the attached form. - If you do not have an affected lot number on the list (see page 2), YOU CAN CONTINUE TO USE THE WRENCHES. Check the box I do not have any affected products on the list - If you do have product(s) on the affected lot number list, AND THEY ARE STILL IN THE BOX, determine if the box also has a green dot sticker as in the photo below. If so, YOU CAN CONTINUE TO USE THE WRENCHES. Check the box I do not have any affected products on the list on page 2. 3. Complete the other information on the form if you do or do not have affected products, return the form by email or fax as indicated on the form. Keep a copy of the form for your records. When your form is received, if you have noted you have affected products Customer Service will contact you and provide an RMA number and directions to return the product, as well as input an order to replace the quantity you indicated on the form. Should you have any questions regarding these instructions, please contact Customer Service at 1-855-532-1723. We apologize for any inconvenience this may cause and thank you for your cooperation in this effort.
Quantity in commerce: 3,984 devices packaged as 6 devices / box (664 boxes)
Distribution: Worldwide Distribution - USA (nationwide) including the countries of Australia, Canada, and Switzerland.
Product codes and lots: Product/Catalog Number C5601; Lot Numbers 1132424, 1132883, 1132884, 1133453, 1133454, 1133455, 1134067, 1134675, 1134873 and 1135014

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1522-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1522-2014	Class II	Terminated	Voluntary: Firm initiated	2014-05-07	2014-04-29

Product code LFL

K981262UnclassifiedCusa Excel Ultrasonic Surgical Aspirator SystemValleylab, Inc. / cleared 1998-07-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)