Screw Recall: Medartis APTUS 2.8 TriLock 16mm
Announced 2026-06-17 · FDA
The recall concerns Medartis AG APTUS 2.8 TriLock Screw 16mm, HD7, 1/Pkg (Lot 25467933) due to a mix-up between specified lots of 2.5mm and 2.8mm outer diameter screws. It is worldwide with US distribution in Indiana and Pennsylvania and other listed countries; 126 units are involved. No corrective action is provided in the recall notice.
| Brand | Medartis AG |
|---|---|
| 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 | Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws. |
| Severity | moderate |
| Units affected | 13 |
| 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. |
| Agency | FDA |
| Recall / campaign no. | Lot Code: Version or Model: A-5850.16/1 Device Description: 2.8 TriLock Screw 16mm, HD7, 1/Pkg Lot: 25467933 |
WHAT YOU SHOULD DO
- If you are treated with this implant, contact your surgeon or hospital to determine if your device is affected by the lot 25467933.
- Do not attempt to remove or modify the implant yourself; follow your healthcare provider's instructions.
- Report any adverse events or concerns to your surgeon and the medical device manufacturer; keep the recall reference number for reference.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.