The Recall Desk
ModerateFDA (Devices)·Z-0919-2020·Announced 2020-02-05

Arthrex Fibulock Fibular Nail Instrument Set Recalled for Potential Blockage

Arthrex, Inc. is recalling 47 units of the Fibulock Fibular Nail Instrument Set due to a potential for blockage of the Hub Attachment Tube.

What this means for you

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 potential mechanical issue (blockage) without reporting any injuries, illnesses, or deaths, fitting the criteria for a moderate severity recall.

Plain-English summary

Arthrex, Inc. is recalling 47 units of the Fibulock Fibular Nail Instrument Set, specifically the Reusable non-sterile instruments and Outrigger Targeting Guide. The recall is being conducted because there is a potential for blockage of the Hub Attachment Tube.

The affected products were distributed nationwide in the United States. No distribution outside the US is reported. The specific batch/lot number for the recalled items is 051838.

Consumers and healthcare facilities should stop using the affected instruments and contact Arthrex, Inc. for further instructions on how to proceed with the recall.

The recalled product

Product
Arthrex Fibulock Fibular Nail Instrument Set Reusable non-sterile instruments Outrigger Targeting Guide
Manufacturer
Arthrex, Inc.
Affected units
47

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)

  • Batch/Lot 051838

Distribution

Distributed nationwide across the United States.