The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2067-2020·Announced 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.

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 FDA Class II. The hazard involves a labeling error that could 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 228 units of DFINE Vertebral Hydraulic Assemblies, part of the StabiliT Vertebral Augmentation System. The product is intended for the percutaneous delivery of StabiliT ER2 Bone Cement in kyphoplasty procedures to treat pathological fractures of the vertebrae.

The recall was initiated because the labels on the affected products display an incorrect expiration date. The product's validated shelf life is two years, but the labels indicate a five-year expiration date. The affected product is scheduled to begin expiring in March 2020.

Using the product beyond its validated shelf life may result in the product not functioning as intended or cause a delay in the procedure or the need to reschedule it. The affected units were distributed worldwide, including in the United States and in Germany, Switzerland, and New Zealand.

The recalled product

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…
Manufacturer
Merit Medical Systems, Inc.
Category
Medical Device — Orthopedic / Spinal
Hazard
Affected units
228

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 (6)

  • 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.

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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