Z-0919-2020Class II

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

Name: Z-0919-2020 Arthrex Fibulock Fibular Nail Instrument Set Reusable non-sterile instruments Outrigger Targeting Guide
Creator: Arthrex, Inc.
Published: 2019-12-17
License: https://open.fda.gov/license/

Arthrex GmbH / initiated 2019-12-17 / Terminated / root cause: manufacturing process

FDA source

Arthrex, Inc. began a recall of Arthrex Fibulock Fibular Nail Instrument Set Reusable non-sterile instruments Outrigger Targeting Guide on 2019-12-17. FDA classified it as Class II and gives the reason as "There is a potential for blockage of the Hub Attachment Tube". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0919-2020
Classification: Class II
Status: Terminated
Initiated: 2019-12-17
Posted: 2020-01-30
Terminated: 2023-08-31
Recalling firm: Arthrex GmbH
Product: Arthrex Fibulock Fibular Nail Instrument Set Reusable non-sterile instruments Outrigger Targeting Guide
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: There is a potential for blockage of the Hub Attachment Tube.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Consignees were notified via e-mail with recall letter dated 12/17/2019. The letter identified affected product, reason for recall, and instructed consignee to immediately discontinue use, sale, and distribution of the product as well instructions for handling of affected product.
Quantity in commerce: 47
Distribution: Nationwide in US; no distribution OUS.
Product codes and lots: Batch/Lot 051838

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0919-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0919-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-05	2020-01-30

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)