Medartis Inc. recalls APTUS 2.8 TriLock Screw 22mm, HD7, 1/Pkg. Metal bone fixation fastener used with the APTUS fixation system.
- Recall date
- April 12, 2024
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1821-2024
- FDA classification
- Class II
- Brand / firm
- Medartis Inc.
- Sold / distributed
- Worldwide - US Nationwide distribution in the state of TX and the countries of Australia, Czech Republic, Finland, France, Germany, Poland, South Africa, & Switzerland.
Why it was recalled
Screw is 16mm long instead of 22mm long.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
APTUS 2.8 TriLock Screw 22mm, HD7, 1/Pkg. Metal bone fixation fastener used with the APTUS fixation system.
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