The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2068-2020·Announced 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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as Moderate because it involves a labeling error (incorrect expiration date) that may lead to product malfunction or procedural delays, but the source text does not report any injuries, illnesses, or deaths.

Plain-English summary

Merit Medical Systems, Inc. is recalling 63 units of DFINE Vertebral Assemblies, specifically the Hydraulic-Master Syringe Assembly and StabiliT Vertebral Augmentation System (Reference/Catalog number 3427). The product is intended for percutaneous delivery of StabiliT ER2 Bone Cement in kyphoplasty procedures for the treatment of pathological fractures of the vertebrae.

The recall was initiated because the product labels display an incorrect expiration date. The product's validated shelf-life is two years, but the labels print a five-year expiration date. The affected product begins expiring in March 2020. Using the product beyond the validated shelf-life may result in the product not functioning as intended or cause a delay in the procedure or the need for the procedure to be rescheduled.

The affected units were distributed worldwide, including nationwide in the United States (specifically in TX, UT, PA, KY, AR, and CA) and in Germany, Switzerland, and New Zealand. The recall includes one government/military consignee in Kentucky. The affected lot numbers are AAE-1904-01 and AAE-1908-10.

The recalled product

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…
Manufacturer
Merit Medical Systems, Inc.
Category
Medical Device — Orthopedic / Spinal
Hazard
Affected units
63

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot number: AAE-1904-01 and UDI: (01)00884450374375(17)240331(10)AAE-1904-01
  • Lot number: AAE-1908-10 and UDI: (01)00884450374375(17)240731(10)AAE-1908-10.

Distribution

Distributed nationwide across the United States.

The notice also names 7 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Merit Medical Systems, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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