Class 2 Device Recall Integra CUSA Excel Sterile Torque Wrench (23 kHz)

• Date Initiated by Firm: March 10, 2014
• Date Posted: April 29, 2014
• Recall Status: Terminated on February 13, 2015
• Recall Number: Z-1522-2014
• Recall Event ID: 67902
• 510(K)Number: K981262
• Product Classification: Instrument, ultrasonic surgical - Product Code LFL
• 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.
• Code Information: Product/Catalog Number C5601; Lot Numbers 1132424, 1132883, 1132884, 1133453, 1133454, 1133455, 1134067, 1134675, 1134873 and 1135014
• Recalling Firm/ Manufacturer: Integra LifeSciences Corp.; 311 Enterprise Dr; Plainsboro NJ 08536-3344
• For Additional Information Contact: Customer Service; 609-275-0500
• Manufacturer 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 Determined 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = LFL