Recall Z-1218-2024 ยท HRS Plate, Fixation, Bone
Acumed LLC
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
| Date | Feb 29, 2024 (initiated Dec 19, 2023) |
| Status | Open, Classified |
| Reason | Distribution without Pre-Market Clearance |
| Root cause | No Marketing Application |
| Action | Between the dates of January 24-25, 2023 Acumed Urgent: Medical Device Correction Notification to consignees via: USPS. Acumed asked consignees to take the following steps: This notice is solely for your awareness. Products within the scope of this correction do not need to be returned to Acumed. Until the products have received Pre-Market clearance, please post this Customer Notification on or near the affected products to be continuously informed of the situation. Physicians are urged to notify Acumed of any adverse events or product safety issues. Additionally, adverse reactions or qual |
| Quantity | 2,952,121 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of AE, AR, AU, BE, BR, CA, CH, CL, CN, CO, CR, DE, DK, EC, ES, FI, FR, GB, GT, HK, ID, IE, IL, IT, JP, KR, KW, MX, MY, NZ, PA, PE, PR, PT, QA, SA, SE, SG, TH, TR, TW, US, ZA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.