Brand Name: APTUS Product Name: 2 — Class II medical device recall Z-1549-2026
Ongoing recall by Medartis AG, reported 2026-03-18, distributed nationwide. Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws.
| Recall number | Z-1549-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medartis AG, Basel Town, N/A, Switzerland |
| Recall initiated | 2026-01-09 |
| Classified | 2026-03-10 |
| Reported by FDA | 2026-03-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BE, CH, CZ, DE, ES, FI, FR, IL, IT, JP, PL |
| Quantity | 0 |
| Lot numbers | 25472432 |
| Model numbers | A-5750.16/1 |
Product
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.
Reason for recall
Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1549-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.