The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0062-2014·Announced 2013-10-30

Integra Licox Brain Tissue Oxygen Monitoring Kit Recall 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 corresponds to a moderate severity level where the use of the product could cause temporary or medically reversible health consequences, or where there is a remote probability of serious adverse health consequences. No injuries or illnesses are reported in the source text.

Plain-English summary

Integra LifeSciences Corporation is recalling Licox Brain Tissue Oxygen and Temperature Catheter Kits. The recall is due to a possibility that some lots contain a hex wrench that does not loosen the set screw on the drill bit.

The affected product is the Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit, manufactured by GMS- Gesellschaft fur medizinische, Sondentechnik mbH and distributed by Integra Neurosciences. The specific lot number is 170812. The recall involves 6 non-US kits that were distributed worldwide, including in the United States and various international locations.

Healthcare providers and facilities should stop using the affected kits and contact the manufacturer for instructions on replacement or return. This recall addresses a functional defect in the included tooling rather than a direct contamination or labeling error.

The recalled product

Product
Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IM3.S_.EU 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.
Category
Medical Device — Neurological Monitoring
Hazard
Affected units
6

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 (1)

  • Lot #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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