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Recall Observatory FDA recall evidence

Device product

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

Z-0919-2020

December 17, 2019

Class II

Product summary

Firm
Arthrex, Inc.
Event
Event 84594
Status
Terminated
Classification
Class II
Quantity
47
Official record key
device-enforcement:Z-0919-2020

Official wording

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

Code information: Batch/Lot 051838

Distribution pattern: Nationwide in US; no distribution OUS.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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