Class 3 Device Recall

• Date Initiated by Firm: September 13, 2005
• Date Posted: November 16, 2005
• Recall Status: Terminated on October 03, 2006
• Recall Number: Z-0141-06
• Recall Event ID: 33454
• 510(K)Number: K021989
• Product Classification: Instrument, Ultrasonic Surgical - Product Code LFL
• Product: Selector Ultrasonic Integra Ultrasonic Aspirator System, Model 1523211 and 1523215, 24kHz Neuro Short Sterile Tip Set.
• Code Information: Lot 050-779, Model # 1523211; Lot 050-779, Model # 1523215.
• 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: Integra became aware that certain Model 24kHz Neuro Short Sterile tip Sets were inadvertently packaged with the incorrect 35kHz Neuro Flues.
• FDA Determined Cause: Other
• Action: FedEx packages were sent out to their customers 9/13/2005.
• Quantity in Commerce: 24 (four 1 packs)(four 5 packs)
• Distribution: The product is distributed directly to the firm''s sales representatives and direct accounts.
• 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