Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws.
Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Medartis AG or your healthcare provider for instructions. Notification method: Letter
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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: Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws.. Classification: Class II. Quantity: 126. 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.
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