Z-0059-2014Class II

Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IM1.S Rx Only, Manufacturer...

Name: Z-0059-2014 Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IM1.S Rx Only, Manufacturer...
Creator: Integra LifeSciences Corp.
Published: 2013-06-11
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2013-06-11 / Terminated / root cause: manufacturing process

FDA source

Integra LifeSciences Corp. began a recall of Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IM1.S Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH... on 2013-06-11. FDA classified it as Class II and gives the reason as "Integra LifeSciences Corporation has determined that there is a possibility that some lots of Licox CMP Brain Tissue Oxygen and Temperature Catheter Kits contain a hex wrench that does not loosen the set screw on the...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0059-2014
Classification: Class II
Status: Terminated
Initiated: 2013-06-11
Posted: 2013-10-23
Terminated: 2014-02-18
Recalling firm: Integra LifeSciences Corporation
Product: Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IM1.S Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Used in direct monitoring of the partial pressure of oxygen.
Product code: GWM Device, Monitoring, Intracranial Pressure
Reason for recall: Integra LifeSciences Corporation has determined that there is a possibility that some lots of Licox CMP Brain Tissue Oxygen and Temperature Catheter Kits contain a hex wrench that does not loosen the set screw on the drill bit.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Integra LifeSciences Corporation sent a recall letter/return response form on 6/11/2013 by traceable courier service, traceable e-mail or facsimile.
Quantity in commerce: 16 KITS
Distribution: Worldwide distribution: US (nationwide) and countries of: AR, BR, CH, CL,CR. DE, ES, FI, FR, GB, IL, IT, MX, PA, PL, PT, RU, TW, and ZA.
Product codes and lots: K002765 Lot # 090812, 170812

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0059-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0054-2014	Class II	Terminated	Voluntary: Firm initiated	2013-10-30	2013-10-23
Z-0055-2014	Class II	Terminated	Voluntary: Firm initiated	2013-10-30	2013-10-23
Z-0056-2014	Class II	Terminated	Voluntary: Firm initiated	2013-10-30	2013-10-23
Z-0057-2014	Class II	Terminated	Voluntary: Firm initiated	2013-10-30	2013-10-23
Z-0058-2014	Class II	Terminated	Voluntary: Firm initiated	2013-10-30	2013-10-23
Z-0059-2014	Class II	Terminated	Voluntary: Firm initiated	2013-10-30	2013-10-23
Z-0060-2014	Class II	Terminated	Voluntary: Firm initiated	2013-10-30	2013-10-23
Z-0061-2014	Class II	Terminated	Voluntary: Firm initiated	2013-10-30	2013-10-23
Z-0062-2014	Class II	Terminated	Voluntary: Firm initiated	2013-10-30	2013-10-23
Z-0063-2014	Class II	Terminated	Voluntary: Firm initiated	2013-10-30	2013-10-23

Product code GWM

K040235Class IILicox Pmo Brain Monitoring SystemIntegra LifeSciences Corporation / cleared 2004-04-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)