medical Class II Updated 2023-09-13

Aesculap Implant Systems LLC recalls For intraventricular indications mainly used for operations

Recalled Product

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

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)

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

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