The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0059-2014·Announced 2013-10-30

Integra Licox Brain Tissue Oxygen Monitoring Kits Recalled for Defective Hex Wrench

Integra LifeSciences is recalling 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, which typically indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. The defect is a mechanical issue with an accessory tool (hex wrench) rather than a direct contamination or failure of the primary monitoring sensor, and no injuries or illnesses are reported in the source text.

Plain-English summary

Integra LifeSciences Corporation is recalling 16 kits of the Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit (REF IM1.S). The recall affects specific lots identified by code K002765 and lot numbers 090812 and 170812. The product is distributed worldwide, including in the United States and various international markets.

The recall was initiated because the company determined that some of the affected kits may contain a hex wrench that does not properly loosen the set screw on the drill bit. This defect could potentially interfere with the proper use of the device for monitoring the partial pressure of oxygen in brain tissue.

Healthcare providers and facilities that have received these specific kits should stop using them and contact Integra LifeSciences for further instructions on how to return or dispose of the product. Consumers should not use the device if they have received it and should contact their healthcare provider for guidance.

The recalled product

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…
Manufacturer
Integra LifeSciences Corp.
Category
Medical Device — Neurological Monitoring
Hazard
Affected units
16

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 (2)

  • K002765 Lot # 090812
  • 170812

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.

See all 10 products in this recall →

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