Arthrex product recalled over sterility concerns
- Recall date
- December 17, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Arthrex, Inc. recalls Arthrex Fibulock Fibular Nail Instrument Set Reusable non-sterile instruments Outrigger Targeting Guide
- Recall number
- Z-0919-2020
- FDA classification
- Class II
- Brand / firm
- Arthrex, Inc.
- Sold / distributed
- Nationwide in US; no distribution OUS.
Why it was recalled
There is a potential for blockage of the Hub Attachment Tube.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Arthrex Fibulock Fibular Nail Instrument Set Reusable non-sterile instruments Outrigger Targeting Guide
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