FDA recall, , Moderate risk
Medartis APTUS TriLock Screws
APTUS TriLock Screws may be mixed up between specified lots of 2.5mm and 2.8mm outer diameter screws.
Summary by Recall Canary from the FDA notice
What happened
Medartis AG, based in Basel Town, Switzerland, voluntarily recalled certain APTUS TriLock Screws because of a mix up between specified lots of 2.5mm and 2.8mm outer diameter screws. The recall involves the Aptus 2.8 TriLock Screw 16mm, model/catalog number A-5850.16/1, with a quantity of 126 units. The APTUS fixation systems are used for fractures, osteotomies and arthrodesis of the hand, forearm, shoulder and foot.
The company began the recall on January 9, 2026, and customers were notified by letter. The recall was added to the FDA's Enforcement Report and classified on March 10, 2026, and included in the FDA's weekly enforcement report on March 18, 2026. Distribution was worldwide, including US nationwide distribution in Indiana and Pennsylvania, and the countries of Austria, Belgium, Switzerland, Czech Republic, Germany, Spain, Finland, France, Israel, Italy, Japan, and Poland.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
2 products
Match the lot code and model/catalog number listed under your product.
APTUS 2.5 TriLock Screw 16mm, HD7, 1/Pkg
- Model/Catalog number
- A-5750.16/1
- Lot code
- 2.5
- 16mm
- HD7
- 25472432
APTUS 2.8 TriLock Screw 16mm, HD7, 1/Pkg
- Model/Catalog number
- A-5850.16/1
- Lot code
- 2.8
- 16mm
- HD7
- 25467933
Recall details
- Company began the recall
- Sold in
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.
- Company
- Medartis AGBasel Town, Switzerland
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98353
- Recall numbers
- Z-1549-2026 to Z-1550-2026
- Recall type
- Voluntary: Firm initiated
- How the company first told customers
- Letter
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
