APTUS 2.8 TriLock Screw 22mm, HD7, 1/Pkg. Metal bone fixation fastener used with the APTUS fixati...
FDA Recall #Z-1821-2024 — Class II — April 12, 2024
Product Description
APTUS 2.8 TriLock Screw 22mm, HD7, 1/Pkg. Metal bone fixation fastener used with the APTUS fixation system.
Reason for Recall
Screw is 16mm long instead of 22mm long.
Recalling Firm
Medartis Inc. — Warsaw, IN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
110 units
Distribution
Worldwide - US Nationwide distribution in the state of TX and the countries of Australia, Czech Republic, Finland, France, Germany, Poland, South Africa, & Switzerland.
Code Information
Part No. A-5850.22/1; UDI-DI: 76300378022PA; Lot No. 24377397.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated