FDA-Device2026-03-18Class IIMISBRANDING
Medartis APTUS 2.5 TriLock Screw recalled for size mix-up risk
What this means
Medartis AG recalled specific lots of APTUS 2.5 TriLock Screws used in hand, forearm, shoulder, and foot surgery because some packages may contain 2.8mm screws instead of the labeled 2.5mm size. Using the wrong size screw could affect surgical fixation.
- If you have lot 25472432, verify the screw size before use
- Contact Medartis or your surgical supplier if you have affected screws
- Do not use screws from this lot if the size cannot be confirmed
The agency's original wording
Hazard
Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws.
Intended for
Adults
Illnesses reported
None reported
Sold states
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.
Affected count
0
Manufactured in
Hochbergerstrasse 60e, N/A, Basel Town, N/A, Switzerland
Products
Brand Name: APTUS Product Name: 2.5 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A-5750.16/1 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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1549-2026Want us to check the next one for you?
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