Reported May 27, 2020 · Terminated
DFINE Vertebral Assemblies: Hydraulic-Master Syringe Assembly, StabiliT Vertebral Augmentation System,…
Merit Medical Systems, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Merit Medical Systems, Inc. · 1600 W Merit Pkwy · South Jordan, UT · 84095-2416
Is this the product you have?
- DFINE Vertebral AssembliesHydraulic-Master Syringe Assembly, StabiliT Vertebral Augmentation System, Reference/Catalog
- number 3427 - Product Usageis 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)
- Lot codes and dates
- Lot numberAAE-1904-01
- and UDI(01)00884450374375(17)240331(10)AAE-1904-01
- Lot numberAAE-1908-10
- and UDI(01)00884450374375(17)240731(10)AAE-1908-10
- Amount recalled
- 63
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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