Medical device recalls Moderate risk

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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