FDA recall Z-1550-2026

Medartis AG · Class II · device

Product

Brand Name: APTUS Product Name: 2.8 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A-5850.16/1 Software Version: Not applicable. Product Description: The APTUS fixation systems are used for fractures, osteotomies and arthrodesis of the hand, forearm, shoulder and foot. Component: Not applicable.

Reason for recall

Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws.

Distribution

Worldwide - US Nationwide distribution in the states of Indiana and Pennsylvania and the countries of Austria, Belgium, Switzerland, Czech Republic, Germany, Spain, Finland, France, Israel, Italy, Japan, and Poland.

Key facts

Status
Ongoing
Initiation date
2026-01-09
Report date
2026-03-18
Voluntary/Mandated
Voluntary: Firm initiated
Location
Basel Town, N/A, Switzerland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1550-2026