DFINE Vertebral Hydraulic Assemblies: Hydraulic Assembly — Class II medical device recall Z-2067-2020
Terminated recall by Merit Medical Systems, Inc., reported 2020-05-27, distributed nationwide. Vertebral hydraulic assemblies has incorrect expiration date printed on the labels.The product's shelf-life is
| Recall number | Z-2067-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Merit Medical Systems, Inc., South Jordan, UT, United States |
| Recall initiated | 2020-02-13 |
| Classified | 2020-05-21 |
| Reported by FDA | 2020-05-27 |
| Terminated | 2021-02-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | CH, DE, NZ |
| Quantity | 228 |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00884450374399 |
| Lot numbers | AAD-1801-16, AAD-1801-17, AAD-1803-01, AAD-1804-05, AAD-1901-07, AAD-1904-04 |
| Model numbers | 1402 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2067-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.