Z-0919-2020 Class II Terminated

Recalled by Arthrex, Inc. — Naples, FL

FDA device recall Z-0919-2020 was initiated by Arthrex, Inc. on December 17, 2019 and is designated Class II. Reason for recall: There is a potential for blockage of the Hub Attachment Tube. The recall status is terminated (terminated August 31, 2023). Affected quantity: 47.

Recall Details

Product Type
Devices
Report Date
February 5, 2020
Initiation Date
December 17, 2019
Termination Date
August 31, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
47

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.

Distribution Pattern

Nationwide in US; no distribution OUS.

Code Information

Batch/Lot 051838