Class 2 Device Recall INTEGRA NEUROSCIENCESSuture CollarsNon Sterile for Single Use Only

• Date Initiated by Firm: November 28, 2011
• Date Posted: February 16, 2012
• Recall Status: Terminated on October 29, 2013
• Recall Number: Z-1049-2012
• Recall Event ID: 60599
• 510(K)Number: K811288 K854049
• Product Classification: Shunt, central nervous system and components - Product Code JXG
• Product: "***REF NL82059-02***INTEGRA NEUROSCIENCES***Suture Collars***Non Sterile for Single Use Only***Plainsboro, NJ***" Collars for lumbar peritoneal shunt
• Code Information: 1021597, 1031020, 1071033, 1092906, 1094646, 1100128, 1101134
• Recalling Firm/ Manufacturer: Integra Neurosciences PR, Inc.; Carr 402 Norte Km 1.2; Anasco PR 00610
• For Additional Information Contact: 787-826-2329
• Manufacturer Reason for Recall: The current packaging configuration for the non-sterile shunt accessories could lead to the potential for confusion regarding product sterility.
• FDA Determined Cause: Labeling mix-ups
• Action: Integra sent an Urgent Product Recall Notification letter dated November 28, 2011. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to fill out and sign the attached Recall Acknowledgement Form noting the part numbers, lot numbers and quantity of the affected product in their inventory. Customers were asked to contact Integra LifeSciences Corporation International Customers Service at 609-936-5400 to arrange for Returns. If customers do not have any of the affected product in their inventory they are required to complete and sign the form and indicate they have NO affected product in their inventory. Customers should fax or email their Recall Acknowledgement Form to: 609-750-4259 or LAPAC_CS@Integralife.com For questions call 609-936-2495.
• Quantity in Commerce: 63 units
• Distribution: Worldwide Distribution - USA (nationwide) and the countries of Austria, Canada, Italy, Australia
• 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 = JXG; 510(K)s with Product Code = JXG