FDA Device recall Z-2361-2026
Medartis APTUS, 5.0 headedCCS Long Thread 50/20mm, REF A-8216.50/1, 1/Pkg
- FDA Device
- Class II
- ongoing
- Published 2026-06-17
On 2026-06-17 the FDA classified a Class II recall of Medartis APTUS, 5.0 headedCCS Long Thread 50/20mm, REF A-8216.50/1, 1/Pkg by Medartis Ag, citing the cannulation of the CCS screw is not centered.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2361-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-04-24 |
| Published | 2026-06-17 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Medartis Ag |
| Distribution | US |
Product
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.
Identifiers
| code_info | UDI/DI 07630037887706, Lot Numbers: 25444702, 24425542, 24404471, 25441997 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2361-2026%22
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