Recall Z-1550-2026 ยท HWC Screw, Fixation, Bone
Medartis AG
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.
| Date | Mar 10, 2026 (initiated Jan 9, 2026) |
| Status | Open, Classified |
| Reason | Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws. |
| Root cause | Labeling mix-ups |
| Action | Firm began notifying affected customers on January 13, 2026 via email. Customers were instructed to return impacted products to Medartis Inc. |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K091479 | APTUS FOOT SYSTEM Medartis AG, Jul 13, 2009 |