Medical device recalls Moderate risk

Arthrex product recalled over sterility concerns

Recall date
December 17, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Arthrex, Inc. recalls Arthrex Fibulock Fibular Nail Instrument Set Reusable non-sterile instruments Outrigger Targeting Guide
Recall number
Z-0919-2020
FDA classification
Class II
Brand / firm
Arthrex, Inc.
Sold / distributed
Nationwide in US; no distribution OUS.

Why it was recalled

There is a potential for blockage of the Hub Attachment Tube.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Arthrex Fibulock Fibular Nail Instrument Set Reusable non-sterile instruments Outrigger Targeting Guide

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