Brand Name: APTUS recallZ-1549-2026 · Medartis AG · initiated Jan 9, 2026
Class II Open, Classified All recalls posted in March 2026
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medartis AG or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws.
FDA root cause category: Labeling mix-ups
What the company is doing
Firm began notifying affected customers on January 13, 2026 via email. Customers were instructed to return impacted products to Medartis Inc.
Recall details
- Recall number
- Z-1549-2026
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Jan 9, 2026
- Posted by the FDA
- Mar 10, 2026
- Recalling firm
- Medartis AG
- Quantity
- 0
- Product code
- HWC
- FDA submissions
- K051567
- 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.
Product description
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.
Code information (models, lots, serial numbers)
Lot Code: Version or Model: A-5750.16/1 Device Description: 2.5 TriLock Screw 16mm, HD7, 1/Pkg Lot: 25472432
Other devices under the same FDA submission
1 device cleared under K051567 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- APTUS A-5750.18/1Medartis AG · Screw, fixation, bone1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page