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Recall

Class II — Arthrex, Inc.

Recalling firmARTHREX, INC.
Registered facilityView this company's 20 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusTerminated
ReasonThere is a potential for blockage of the Hub Attachment Tube.
ProductArthrex Fibulock Fibular Nail Instrument Set Reusable non-sterile instruments Outrigger Targeting Guide
Quantity47
DistributionNationwide in US; no distribution OUS.
Initiated2019-12-17
Classified2020-01-30
Terminated2023-08-31
Recall numberZ-0919-2020
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Arthrex, Inc. (Z-0919-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/84594/

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