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 vertebra
Check against the official notice below — it lists the full affected range.
Merit Medical Systems, Inc. is recalling DFINE Vertebral Assemblies Hydraulic-Master Syringe Assemblies used in the StabiliT Vertebral Augmentation System (Catalog number 3427) due to incorrect expiration dates printed on product labels. The affected products have a true shelf-life of two years, but the labels indicate a five-year expiration date. Sixty-three units were distributed worldwide, including to locations in Texas, Utah, Pennsylvania, Kentucky, Arkansas, and California, as well as to Germany, Switzerland, and New Zealand. The affected products began expiring in March 2020.
Using these products beyond their validated two-year shelf-life may result in the product not functioning as intended or may cause delays in procedures that need to be rescheduled. The affected lot numbers are AAE-1904-01 and AAE-1908-10. The recall record does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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: 63 Lot/code info: 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.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.