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Recall Observatory FDA recall evidence

Device product

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

Z-2518-2023

July 20, 2023

Class II

Product summary

Firm
Aesculap Implant Systems LLC
Event
Event 92813
Status
Ongoing
Classification
Class II
Quantity
25 units
Official record key
device-enforcement:Z-2518-2023

Official wording

Reason: 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.

Code information: 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

Distribution pattern: US Nationwide distribution in the states of FL, ID, IL, MD, NC, NY, OR, RI, TX.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.