FDA DevicesClass II
Brand Name: APTUS Product Name: 2.5 TriLock Screw 16mm, HD7, 1/Pkg Model/Catal...
Published: March 18, 2026Recall ID: Z-1549-2026Category: devicesCountry: US
Reason for Recall / Hazard
Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws.
Product Description & Identification
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.
Affected 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.
Additional Source Details
| Field | Value |
|---|---|
| City | Basel Town |
| State | N/A |
| Event id | 98353 |
| Address 1 | Hochbergerstrasse 60e |
| Address 2 | N/A |
| Code info | Lot Code: Version or Model: A-5750.16/1 Device Description: 2.5 TriLock Screw 16mm, HD7, 1/Pkg Lot: 25472432 |
| Postal code | N/A |
| Report date | 20260318 |
| Product type | Devices |
| Product quantity | 0 |
| Reason for recall | Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260109 |
| Initial firm notification | Letter |
| Center classification date | 20260310 |
Overview
- Recalling FirmMedartis AG
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide - 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.