Merit Medical Systems, Inc.: DFINE Vertebral Hydraulic Assemblies: Hydraulic Assembly, StabiliT Vertebral Augmentation System, Reference/Catalog number 1402 - Product Usage: is intended for percutaneo

Is my product affected?

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 of the vertebrae. Pa

• UPC 00884450374399

Check against the official notice below — it lists the full affected range.

What happened

Merit Medical Systems, Inc. is recalling 228 vertebral hydraulic assemblies used in the StabiliT Vertebral Augmentation System (Reference/Catalog number 1402) because the labels show an incorrect expiration date. The products have a validated shelf-life of two years, but the labels incorrectly indicate a five-year expiration date. The affected units will begin expiring in March 2020. The recall affects six lot numbers (AAD-1801-16, AAD-1801-17, AAD-1803-01, AAD-1804-05, AAD-1901-07, and AAD-1904-04) distributed worldwide, including throughout the United States in Texas, Utah, Pennsylvania, Kentucky, Arkansas, and California, as well as in Germany, Switzerland, and New Zealand.

Using the product beyond its actual validated shelf-life may cause the product to malfunction or not work as intended, potentially resulting in a delay or the need to reschedule a medical procedure. The source document does not specify a remedy for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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.

Details from the source

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. Distribution: 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). Quantity: 228 Lot/code info: 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.

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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