Merit Medical Systems, Inc.: Medical Device Recall in 2020 - (Recall #: Z-2068-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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 fractures of the vertebrae. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

Product Classification:

Class II

Date Initiated: February 13, 2020

Date Posted: May 27, 2020

Recall Number: Z-2068-2020

Event ID: 85485

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.

Status: Terminated

Product Quantity: 63

Code Information:

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 Pattern:

Worldwide distribution: US Nationwide distribution including in the states of (TX, UT, PA, KY, TX, AR, CA, and PA) which included one (1) government/military consignee in KY; and the countries of (Germany, Switzerland, and New Zealand).

Voluntary or Mandated:

Voluntary: Firm initiated