The Recall Desk

FDA (Devices) recall action 85485

Merit Medical Systems, Inc. recalled 2 products on 2020-05-27

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2020-05-27
Critical
0
Units
291

Why these products were 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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • ModerateFDA (Devices)··2020-05-27

    DFINE Vertebral Hydraulic Assemblies Recalled for Incorrect Expiration Dates

    Merit Medical Systems is recalling 228 DFINE Vertebral Hydraulic Assemblies because the labels display a five-year expiration date instead of the correct two-year shelf life.

    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
    Category
    Distribution
    7 states
  • ModerateFDA (Devices)··2020-05-27

    Merit Medical Recalls DFINE Vertebral Assemblies Due to Incorrect Expiration Dates

    Merit Medical Systems is recalling 63 DFINE Vertebral Assemblies because the labels display a five-year expiration date instead of the correct two-year shelf life.

    Product
    DFINE Vertebral Assemblies: Hydraulic-Master Syringe Assembly, StabiliT Vertebral Augmentation System, Reference/Catalog number 3427 - Product Usage: is intended for percutaneous delivery of StabiliT ER2 Bone Cement in kyphoplasty procedures in the treatment of pathological fract
    Category
    Distribution
    7 states