Medartis AG recalls 126 APTUS 2.8 TriLock Screws 16mm HD7 worldwide. The mix-up between 2.5mm and 2.8mm outer diameter screws could affect fixation. Stop using the device and follow manufacturer recall instructions for disposition.
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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The APTUS fixation systems are used for fractures, osteotomies and arthrodesis of the hand, forearm, shoulder and foot.
A mix-up between 2.5mm and 2.8mm outer diameter screws can result in implant mismatch and potential fixation issues during surgery.
This recall is not part of a broader industry pattern.
Surgeons and patients worldwide may be affected. The practical impact centers on stopping use and ensuring correct implants are used to avoid fixation failure.
FDA recall notice Z-1550-2026 and the Medartis recall notice. Visit the FDA enforcement page linked in the recall posting.
Manufacturer guidance provided; no specific replacement timeline published. Hospitals should follow the recall instructions.
Document device lot numbers, serials, and communications with Medartis and hospital records; keep copies of recall notices.
Model/Catalog: A-5850.16/1. 1/Pkg. Lot: 25467933. Device: APTUS fixation system screws. Sizes: 2.8mm outer diameter, 16mm length. HD7 variant. Sold worldwide; US distribution in Indiana and Pennsylvania.
No injuries or incidents have been reported.
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