FDA-Device2024-05-22Class II

APTUS 2.8 TriLock Screw 22mm, HD7, 1/Pkg. Metal bone fixation fastener used with the APTUS fixation system.

Medartis Inc.
Hazard

Screw is 16mm long instead of 22mm long.

Sold states
Worldwide - US Nationwide distribution in the state of TX and the countries of Australia, Czech Republic, Finland, France, Germany, Poland, South Africa, & Switzerland.
Affected count
110 units
Manufactured in
1195 Polk Dr, N/A, Warsaw, IN, United States
Products
APTUS 2.8 TriLock Screw 22mm, HD7, 1/Pkg. Metal bone fixation fastener used with the APTUS fixation system.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1821-2024

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