Aesculap Implant Systems LLC: For intraventricular indications mainly used for operations within the brain ventricles. Product Code: FF399R

Hazard

Trocar manufactured with the shaft too long and does not meet manufacturing specifications. As a result, when used with the 30¿ neuroendoscope, a portion of the visual field is obscured.

Details from the source

Reason for recall: Trocar manufactured with the shaft too long and does not meet manufacturing specifications. As a result, when used with the 30¿ neuroendoscope, a portion of the visual field is obscured. Distribution: US Nationwide distribution in the states of FL, ID, IL, MD, NC, NY, OR, RI, TX. Quantity: 25 units Lot/code info: UDI-DI: 04038653065547 Lot Numbers: 52750146 52753381, 52756472, 52768317, 52805655, 52812596, 52816570, 52823878, 52830872. Serial Numbers: 4281,4282, 4284,4288, 4289,4291, 4308,4309, 4310, 4312, 4313,4336, 4340,4341, 4342,4402, 4411, 4412, 4413,4414, 4422,4439, 4447,4449, 4450

UPC codes

04038653065547

Source

Official record: FDA (Device enforcement) ↗

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