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U.S. Department of Health and Human Services

Class 2 Device Recall LICOX CMP Tissue Oxygen Monitor

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  Class 2 Device Recall LICOX CMP Tissue Oxygen Monitor see related information
Date Initiated by Firm December 17, 2010
Date Posted March 03, 2011
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = INTEGRA NEUROSCIENCES
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