Recall Z-1550-2026
Medartis AG · initiated January 9, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Lot Code: Version or Model: A-5850.16/1 Device Description: 2.8 TriLock Screw 16mm, HD7, 1/Pkg Lot: 25467933
Reason for recall
Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws.
FDA-determined cause: Labeling mix-ups
Action taken
Firm began notifying affected customers on January 13, 2026 via email. Customers were instructed to return impacted products to Medartis Inc.
Details
- Recall number
- Z-1550-2026
- Initiated
- January 9, 2026
- Posted by FDA
- March 10, 2026
- Product code
- HWC – Screw, Fixation, Bone
- Quantity
- 126
- 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.
- Recalling firm
- Medartis AG, Basel Town
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1549-2026 Class II | Brand Name: APTUS Product Name: 2.5 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number:…Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws. | 01/09/2026Open, Classified |