Device recall
Z-1550-2026: Brand Name: APTUS Product Name: 2.8 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog…
FDA device recall · Class II · Medartis AG
Key facts
| Recall number (Z-number) | Z-1550-2026 |
|---|---|
| Recall event | 98353 |
| 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… |
| Product code | HWC |
| Recalling firm | Medartis AG |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K091479 |
| FEI number | 3003236702 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database