Medartis APTUS recall (Medartis AG)
Medical deviceClass IIOngoing
Summary: Medartis AG is recalling Medartis APTUS, 5.0 headedCCS Long Thread 50/20mm, REF A-8216.50/1, 1/Pkg; Cannulated Compression Screws for bone fixation. Reason: The cannulation of the CCS screw is not centered.
What is being recalled
Medartis APTUS, 5.0 headedCCS Long Thread 50/20mm, REF A-8216.50/1, 1/Pkg; Cannulated Compression Screws for bone fixation
Why
The cannulation of the CCS screw is not centered.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide distribution in the states of LA, TX. IN, CA, NC. (states named: California, Indiana, Louisiana, North Carolina, Texas)
How to tell if yours is affected
UDI/DI 07630037887706, Lot Numbers: 25444702, 24425542, 24404471, 25441997
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2361-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | April 24, 2026 |
| Reported | June 17, 2026 |
| Company | Medartis AG |
| Company location | Basel Town, N/A, Switzerland |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 13 units |
More recalls from Medartis AG · all medical device recalls · recalls from April 2026