Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0063-2014·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 a hex wrench 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 mechanical defect without reporting any injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Integra LifeSciences Corporation has initiated a recall of Licox Brain Tissue Oxygen and Temperature Catheter Kits. 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 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 lots involved are #060712 and #170812. The recall covers 34 non-US kits that were distributed worldwide, including in the United States and various international locations.

Healthcare providers and facilities using these kits should stop using the affected lots and contact the recalling firm for instructions on how to proceed. The defect involves a mechanical component that may prevent proper adjustment of the drill bit.

The recalled product

Product: Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IM3.ST_.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: mechanical-defect
Affected units: 34

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)

Lot #060712
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 →

Same manufacturer · Integra LifeSciences Corp.

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