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Terminated

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

FDA Recall Z-0919-2020 · Posted None

Recalling FirmArthrex, Inc.
Recall StatusTerminated
Product CodeLXH
Date Initiated2019-12-17
Date Terminated2023-08-31
Product Quantity47

Reason for Recall

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

Firm 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.

Root Cause

Process control

Distribution Pattern

Nationwide in US; no distribution OUS.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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