Class 3 Device Recall

• Date Initiated by Firm: November 28, 2005
• Date Posted: January 24, 2006
• Recall Status: Terminated on February 26, 2007
• Recall Number: Z-0431-06
• Recall Event ID: 34203
• 510(K)Number: K021989
• Product Classification: Instrument, Ultrasonic Surgical - Product Code LFL
• Product: Selector Ultrasonic Integra Ultrasonic Aspirator System, Selector 24kHz Microsurgical Sterile Tip Set.
• Code Information: Lot 050678 and Lot 050575.
• FEI Number: 3003418325
• Recalling Firm/ Manufacturer: Integra LifeSciences Corp.; 311 Enterprise Dr; Plainsboro NJ 08536-3344
• For Additional Information Contact: Judith O'Grady; 609-936-2311
• Manufacturer Reason for Recall: Additional Model 24kHz Tip Sets were inadvertently packaged with the incorrect 35kHz Neuro Flues. (2nd recall, same problem see Z-141-6)
• FDA Determined Cause: Other
• Action: Customers were notified of the recall on 11/28/2005 via letter sent by UPS.
• Quantity in Commerce: 536 units
• Distribution: The device is distributed nationwide to hospitals nationwide.
• 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