FDA Device recall Z-1821-2024
APTUS 2.8 TriLock Screw 22mm, HD7, 1/Pkg
- FDA Device
- Class II
- ongoing
- Published 2024-05-22
On 2024-05-22 the FDA classified a Class II recall of APTUS 2.8 TriLock Screw 22mm, HD7, 1/Pkg by Medartis, citing screw is 16mm long instead of 22mm long.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1821-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-04-12 |
| Published | 2024-05-22 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medartis |
| Distribution | US |
Product
APTUS 2.8 TriLock Screw 22mm, HD7, 1/Pkg. Metal bone fixation fastener used with the APTUS fixation system.
Reason
Screw is 16mm long instead of 22mm long.
Identifiers
| code_info | Part No. A-5850.22/1; UDI-DI: 76300378022PA; Lot No. 24377397. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1821-2024%22
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