FDA Device recall Z-2067-2020
DFINE Vertebral Hydraulic Assemblies: Hydraulic Assembly, StabiliT Vertebral Augmentation System, Reference/Catalog number 1402 - Product U…
- FDA Device
- Class II
- terminated
- Published 2020-05-27
On 2020-05-27 the FDA classified a Class II recall of DFINE Vertebral Hydraulic Assemblies: Hydraulic Assembly, StabiliT Vertebral Augmentation System, Reference/Catalog number 1402 - Product U… by Merit Medical Systems, citing vertebral hydraulic assemblies has incorrect expiration date printed on the labels.The product's shelf-life is two (2) years, but the expiration date printed on the labels is five….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2067-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-02-13 |
| Published | 2020-05-27 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Merit Medical Systems |
| Distribution | US |
Product
DFINE Vertebral Hydraulic Assemblies: Hydraulic Assembly, StabiliT Vertebral Augmentation System, Reference/Catalog number 1402 - Product Usage: is intended for percutaneous delivery of StabiliT ER2 Bone Cement in kyphoplasty procedures in the treatment of pathological fractures of the vertebrae. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).
Reason
Vertebral hydraulic assemblies has incorrect expiration date printed on the labels.The product's shelf-life is two (2) years, but the expiration date printed on the labels is five (5) years.The affected product will begin expiring in March 2020. Using product beyond the validated shelf-life may result in (1) product not functioning as intended and/or (2) a delay in procedure or the need for the procedure to be rescheduled.
Identifiers
| code_info | Lot number: AAD-1801-16 and UDI: (01)00884450374399(17)221231(10)AAD-1801-16; Lot number: AAD-1801-17 and UDI: (01)008…Lot number: AAD-1801-16 and UDI: (01)00884450374399(17)221231(10)AAD-1801-16; Lot number: AAD-1801-17 and UDI: (01)00884450374399(17)221231(10)AAD-1801-17; Lot number: AAD-1803-01 and UDI: (01)00884450374399(17)230331(10)AAD-1803-01; Lot number: AAD-1804-05 and UDI: (01)00884450374399(17)230430(10)AAD-1804-05; Lot number: AAD-1901-07 and UDI: (01)00884450374399(17)231231(10)AAD-1901-07; Lot number: AAD-1904-04 and UDI: (01)00884450374399(17)240430(10)AAD-1904-04. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2067-2020%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.