—#96520

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.

FDA product code: GWM — Device, Monitoring, Intracranial Pressure
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K002765
Affected lot / code info: 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.

Why it was recalled

Certain LICOX CMP Tissue Oxygen Monitors could allow for underestimation of temperature values.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Integra LifeSciences Corp.
Address: 311 Enterprise Dr, Plainsboro, New Jersey 08536-3344

Distribution

Distribution pattern: Worldwide Distribution

Timeline

Recall initiated: 2010-12-17
Posted by FDA: 2011-03-03
Terminated: 2012-11-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #96520. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.