Arthrex Fibulock Fibular Nail Instrument Set Reusable non-sterile instruments Outrigger Targeti...

FDA Recall #Z-0919-2020 — Class II — December 17, 2019

Recall #Z-0919-2020 Date: December 17, 2019 Classification: Class II Status: Terminated

Product Description

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

Reason for Recall

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

Recalling Firm

Arthrex, Inc. — Naples, FL

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

47

Distribution

Nationwide in US; no distribution OUS.

Code Information

Batch/Lot 051838

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated