FDA Device recall Z-0767-2023
Part Number/Part Description: 30-0033-S 30mm Acutrak¿ Fusion Device 6mm Nose AM-0025-S 25.0mm Acutrak¿ 4/5 Bone Screw AM-0030-S 30.0mm Acut…
- FDA Device
- Class II
- ongoing
- Published 2023-01-04
On 2023-01-04 the FDA classified a Class II recall of Part Number/Part Description: 30-0033-S 30mm Acutrak¿ Fusion Device 6mm Nose AM-0025-S 25.0mm Acutrak¿ 4/5 Bone Screw AM-0030-S 30.0mm Acut… by Acumed, citing distribution without Pre-Market Clearance.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0767-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-11-29 |
| Published | 2023-01-04 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Acumed |
| Distribution | US |
Product
Part Number/Part Description: 30-0033-S 30mm Acutrak¿ Fusion Device 6mm Nose AM-0025-S 25.0mm Acutrak¿ 4/5 Bone Screw AM-0030-S 30.0mm Acutrak¿ 4/5 Bone Screw AM-0035-S 35.0mm Acutrak¿ 4/5 Bone Screw AM-0040-S 40.0mm Acutrak¿ 4/5 Bone Screw AM-0045-S 45.0mm Acutrak¿ 4/5 Bone Screw AM-0050-S 50.0mm Acutrak¿ 4/5 Bone Screw AP-67100-S 100mm Acutrak¿ 6/7 Fixation Screw AP-67105-S 105mm Acutrak¿ 6/7 Fixation Screw AP-67110-S 110mm Acutrak¿ 6/7 Fixation Screw AP-67115-S 115mm Acutrak¿ 6/7 Fixation Screw AP-67120-S 120mm Acutrak¿ 6/7 Fixation Screw AP-6740-S 40mm Acutrak¿ 6/7 Fixation Screw AP-6745-S 45mm Acutrak¿ 6/7 Fixation Screw AP-6750-S 50mm Acutrak¿ 6/7 Fixation Screw AP-6755-S 55mm Acutrak¿ 6/7 Fixation Screw AP-6760-S 60mm Acutrak¿ 6/7 Fixation Screw AP-6765-S 65mm Acutrak¿ 6/7 Fixation Screw AP-6770-S 70mm Acutrak¿ 6/7 Fixation Screw AP-6775-S 75mm Acutrak¿ 6/7 Fixation Screw AP-6780-S 80mm Acutrak¿ 6/7 Fixation Screw AP-6785-S 85mm Acutrak¿ 6/7 Fixation Screw AP-6790-S 90mm Acutrak¿ 6/7 Fixation Screw AP-6795-S 95mm Acutrak¿ 6/7 Fixation Screw ATF-140-S 14.0mm Acutrak¿ Fusion Device ATF-160-S 16.0mm Acutrak¿ Fusion Device ATF-180-S 18.0mm Acutrak¿ Fusion Device ATF-200-S 20.0mm Acutrak¿ Fusion Device ATF-220-S 22.0mm Acutrak¿ Fusion Device ATF-240-S 24.0mm Acutrak¿ Fusion Device ATF-270-S 27.0mm Acutrak¿ Fusion Device ATF-320-S 32.0mm Acutrak¿ Fusion Device ATF-370-S 37.0mm Acutrak¿ Fusion Device ATM-100-S 10.0mm Mini Acutrak¿ Fixation Screw ATM-120-S 12.0mm Mini Acutrak¿ Fixation Screw ATM-140-S 14.0mm Mini Acutrak¿ Fixation Screw ATM-160-S 16.0mm Mini Acutrak¿ Fixation Screw ATM-180-S 18.0mm Mini Acutrak¿ Fixation Screw ATM-200-S 20.0mm Mini Acutrak¿ Fixation Screw ATM-220-S 22.0mm Mini Acutrak¿ Fixation Screw ATM-240-S 24.0mm Mini Acutrak¿ Fixation Screw ATM-260-S 26.0mm Mini Acutrak¿ Fixation Screw
Reason
Distribution without Pre-Market Clearance
Identifiers
| code_info | Acutrak Fusion Device Batch Number/Part Number/Part Description/UDI Code: W73862 30-0033-S 30mm Acutrak¿ Fusion Device…Acutrak Fusion Device Batch Number/Part Number/Part Description/UDI Code: W73862 30-0033-S 30mm Acutrak¿ Fusion Device 6mm Nose 10806378015595-W73862000000151231 W73867 30-0033-S 30mm Acutrak¿ Fusion Device 6mm Nose 10806378015595-W73867000000160130 W73860 30-0033-S 30mm Acutrak¿ Fusion Device 6mm Nose 10806378015595-W73860000000160131 W73865 30-0033-S 30mm Acutrak¿ Fusion Device 6mm Nose 10806378015595-W73865000000160131 W73866 30-0033-S 30mm Acutrak¿ Fusion Device 6mm Nose 10806378015595-W73866000000160131 W73868 30-0033-S 30mm Acutrak¿ Fusion Device 6mm Nose 10806378015595-W73868000000160131 W73863 30-0033-S 30mm Acutrak¿ Fusion Device 6mm Nose 10806378015595-W73863000000160131 230712 30-0033-S 30mm Acutrak¿ Fusion Device 6mm Nose 10806378015595-230712000000170630 233448 30-0033-S 30mm Acutrak¿ Fusion Device 6mm Nose 10806378015595-233448000000170831 237340 30-0033-S 30mm Acutrak¿ Fusion Device 6mm Nose 10806378015595-237340000000171130 241394 30-0033-S 30mm Acutrak¿ Fusio |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0767-2023%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.