FDA Device recall Z-1218-2024
Acu-Loc and Acu-Loc 2 bone plates, screws and accessories for the following REF: 70-0045 Acu-Loc VDU Plate Standard, Left
- FDA Device
- Class II
- ongoing
- Published 2024-03-06
On 2024-03-06 the FDA classified a Class II recall of Acu-Loc and Acu-Loc 2 bone plates, screws and accessories for the following REF: 70-0045 Acu-Loc VDU Plate Standard, Left by Acumed, citing distribution without Pre-Market Clearance.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1218-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-12-19 |
| Published | 2024-03-06 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Acumed |
| Distribution | US |
Product
Acu-Loc and Acu-Loc 2 bone plates, screws and accessories for the following REF: 70-0045 Acu-Loc VDU Plate Standard, Left; 70-0045-S Acu-Loc VDU Plate Standard, Left; 70-0046 Acu-Loc VDU Plate Standard, Right; 70-0046-S Acu-Loc VDU Plate Standard, Right; 70-0047 Acu-Loc VDU Plate Long, Left; 70-0047-S Acu-Loc VDU Plate Long, Left; 70-0048 Acu-Loc VDU Plate Long, Right; 70-0048-S Acu-Loc VDU Plate Long, Right; 70-0055 Acu-Loc Dorsal Plate, Standard, left; 70-0055-S Acu-Loc Dorsal Plate, Standard, left; 70-0056 Acu-Loc Dorsal Plate, Standard, Right; 70-0056-S Acu-Loc Dorsal Plate, Standard, Right; 70-0057 Acu-Loc Dorsal Plate, Narrow, Left; 70-0057-S Acu-Loc Dorsal Plate, Narrow, Left; 70-0058 Acu-Loc Dorsal Plate, Narrow, Right; 70-0058-S Acu-Loc Dorsal Plate, Narrow, Right; 70-0331 Divergent Radial Styloid Plate; 70-0331-S Divergent Radial Styloid Plate; 70-0334 Volar Lunate Suture Plate; 70-0334-S Volar Lunate Suture Plate; 70-0335 Dorsal Rim Buttress Plate, Right; 70-0335-S Dorsal Rim Buttress Plate, Right; 70-0336 Dorsal Rim Buttress Plate, Left; 70-0336-S Dorsal Rim Buttress Plate, Left; 70-0337 Dorsal Lunate Plate, Right; 70-0337-S Dorsal Lunate Plate, Right; 70-0338 Dorsal Lunate Plate, Left;
Reason
Distribution without Pre-Market Clearance
Identifiers
| code_info | All Lots; REF Number /UDI Number: 30-0100 10806378094637-331500000000 30-0100 10806378094637-342124000000 30-0100 1080…All Lots; REF Number /UDI Number: 30-0100 10806378094637-331500000000 30-0100 10806378094637-342124000000 30-0100 10806378094637-347940000000 30-0100 10806378094637-369580000000 30-0100 10806378094637-379903000000 30-0100 10806378094637-404624170313 30-0100 10806378094637-414434170728 30-0100 10806378094637-421189171027 30-0100 10806378094637-428663180115 30-0100 10806378094637-438740180329 30-0100 10806378094637-449053180822 30-0100 10806378094637-462420190205 30-0100 10806378094637-476011190723 30-0100 10806378094637-484283191107 30-0100 10806378094637-486858191209 30-0100 10806378094637-489970200120 30-0100 10806378094637-489971200120 30-0100 10806378094637-514064201119 30-0100 10806378094637-526968210426 30-0100 10806378094637-542934210920 30-0100 10806378094637-549407211124 30-0100 10806378094637-559130220324 30-0100 10806378094637-559131220324 30-0100 10806378094637-564636220526 30-0100 10806378094637-564637220526 30-0100 10806378094637-564638220526 30-0100 10806378094637-574209 |
|---|
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-1218-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.