Beaver Xstar Crescent Knife, 2.5mm, 55 degrees, bevel down. Intended for or cataract surgery. REF#: 373809
Check against the official notice below — it lists the full affected range.
Beaver Visitec International, Inc. is recalling Beaver Xstar Crescent Knife instruments in 2.5mm size with 55-degree bevel-down specifications that were distributed nationwide and internationally to Australia, Austria, France, Germany, the Netherlands, Spain, Japan, Russia, South Africa, and the UK. The recalled products, totaling 5,950 units across six lot numbers (6000842, 6002045, 6011609, 6034238, 6040517, and 6042907), contain bevel-up blades instead of the bevel-down blades as labeled. These instruments are intended for use in cataract surgery.
The mislabeling creates a hazard because surgeons expecting bevel-down blades may use instruments configured differently than intended for their procedures. The recall source does not specify what affected consumers or medical facilities should do regarding this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
Product packaged as Beaver Xstar Crescent Knife, 2.5mm, 55 degrees bevel-down blades contain bevel-up blades
Reason for recall: Product packaged as Beaver Xstar Crescent Knife, 2.5mm, 55 degrees bevel-down blades contain bevel-up blades Distribution: Nationwide Foreign: Australia Austria France Germany Netherlands Spain Japan Russia South Africa UK Quantity: 5950 eaches Lot/code info: LOT#: 6000842, 6002045, 6011609, 6034238, 6040517, 6042907. UDI: " Primary: 00886158000594 " Secondary: 30886158000595 " Tertiary: 50886158000599
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.