FDA Medical devices recall ·
APTUS Product Name: 2.8 TriLock Screw 16mm, HD7, 1/Pkg Model recall
- Recall number
- Z-1550-2026
- Date
- (initiated January 9, 2026)
- Company / brand
- Medartis AG
Hochbergerstrasse 60e, Basel Town, N/A, Switzerland - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 126
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot Code: Version or Model: A-5850.16/1 Device Description: 2.8 TriLock Screw 16mm, HD7, 1/Pkg Lot: 25467933
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.
States: Indiana Pennsylvania
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1550-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.