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Aesculap Implant Systems LLC recalls For intraventricular indications mainly used for operations within the brain ventricles. Product Code: FF399R
Recalled September 13, 2023 · FDA recall Z-2518-2023 · Aesculap Implant Systems
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. · FDA Class II
Units
25 units
Sold at
US Nationwide distribution in the states of FL, ID, IL, MD, NC, NY, OR, RI, TX.
Description
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.
Product
For intraventricular indications mainly used for operations within the brain ventricles. Product Code: FF399R
Manufacturer(s)
Aesculap Implant Systems LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →