Class 2 Device Recall LICOX CMP Tissue Oxygen Monitor

• Date Initiated by Firm: December 17, 2010
• Date Posted: March 03, 2011
• Recall Status: Terminated on November 05, 2012
• Recall Number: Z-1518-2011
• Recall Event ID: 57552
• 510(K)Number: K002765
• Product Classification: Intracranial Pressure Monitoring Device - Product Code GWM
• Product: LICOX CMP Tissue Oxygen Monitor; Catalog numbers REF AC31. Manufacturer GMS Gesellschaft fur medizinische, Sondentechnik mbH, Dorfstrasse 2, 24247 Mielkendorf, Germany; Distributed by Integra NeuroSciences, 311 Enterprise Drive, Plainsboro, New Jersey 08536 USA. Used for continuous determination of oxygen partial pressure in cerebrospinal fluid and brain tissue.
• Code Information: Lot/Serial numbers: 1982, 1988, 1990, 1991, 1992, 1993, 1994, 1995, 1996, 1997, 1998, 1999, 2000, 2001, 2003, 2005, 2007, 2008, 2009, 2010, 2011, 2012, 2014, 2046, 2047, 2051, and 2053.
• Recalling Firm/ Manufacturer: Integra LifeSciences Corp.; 311 Enterprise Dr; Plainsboro NJ 08536-3344
• For Additional Information Contact: David Gronostajski; 609-936-6822
• Manufacturer Reason for Recall: Certain LICOX CMP Tissue Oxygen Monitors could allow for underestimation of temperature values.
• FDA Determined Cause: Nonconforming Material/Component
• Action: Integra Life Sciences notified their Integra Neurospecialist via email and their customers via Fed Ex overnight mail on December 17, 2010 with an Urgent: Product Recall letter. The letter identified the affected product and the reason for the recall. The letter states that an Integra Neurospecialist will contact customers to arrange for the return of their Licox monitor to the Service Center for recalibration. A loaner will be provided until the recalibration is complete. The attached "Recall Acknowledgement and Return Form" must be completed and returned to Integra. If there are any additional questions, customers should contact Gary Rabinovich at 609-936-6864.
• Quantity in Commerce: 26 units
• Distribution: Worldwide Distribution
• 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 = GWM