Integra Licox Brain Tissue Oxygen Monitoring Kits Recalled for Defective Hex Wrench
Integra LifeSciences is recalling 109 Licox Brain Tissue Oxygen Monitoring Kits because some contain a hex wrench that may fail to loosen the set screw on the drill bit.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a functional defect (inability to loosen a set screw) without reporting any injuries, illnesses, or deaths, fitting the criteria for a moderate severity recall.
Plain-English summary
Integra LifeSciences Corporation is recalling 109 kits of the Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Tunneling Probe Kit (REF IT2). The recall is due to a determination that some lots of the kits contain a hex wrench that does not loosen the set screw on the drill bit.
The affected product is a medical device used for the direct monitoring of the partial pressure of oxygen. The kits were manufactured by GMS- Gesellschaft fur medizinische Sondentechnik mbH in Germany and distributed by Integra Neurosciences in the United States and internationally. The specific lots affected are identified by code K040244 and lot numbers 190712, 240512, and 280612.
Distribution was worldwide, including the United States (nationwide) and countries such as Argentina, Brazil, Switzerland, Chile, Costa Rica, Germany, Spain, Finland, France, Great Britain, Israel, Italy, Mexico, Panama, Poland, Portugal, Russia, Taiwan, and South Africa. Healthcare providers and patients should check their inventory and contact the manufacturer or distributor for instructions regarding the defective hex wrench.
The recalled product
- Product
- Inegra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Tunneling Probe Kit REF IT2 Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive…
- Manufacturer
- Integra LifeSciences Corp.
- Hazard
- Affected units
- 109
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- K040244 Lot #190712
- 240512
- 280612
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 10 recalled by Integra LifeSciences Corp. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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