Medartis AG: 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

Hazard

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

Details from the source

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. Quantity: 126 Lot/code info: Lot Code: Version or Model: A-5850.16/1 Device Description: 2.8 TriLock Screw 16mm, HD7, 1/Pkg Lot: 25467933

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.