FDA Device recall Z-1549-2026
Brand Name: APTUS Product Name: 2.5 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A-5750.16/1 Software Version: Not applicable
- FDA Device
- Class II
- ongoing
- Published 2026-03-18
On 2026-03-18 the FDA classified a Class II recall of Brand Name: APTUS Product Name: 2.5 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A-5750.16/1 Software Version: Not applicable by Medartis Ag, citing mix up between specified lots of 2.5mm and 2.8mm outer diameter screws.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1549-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-01-09 |
| Published | 2026-03-18 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Medartis Ag |
| Distribution | US |
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
Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws.
Identifiers
| code_info | Lot Code: Version or Model: A-5750.16/1 Device Description: 2.5 TriLock Screw 16mm, HD7, 1/Pkg Lot: 25472432 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1549-2026%22
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