FDA-Device2023-09-13Class II
For intraventricular indications mainly used for operations within the brain ventricles. Product Code: FF399R
Aesculap Implant Systems LLC
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.
Sold states
US Nationwide distribution in the states of FL, ID, IL, MD, NC, NY, OR, RI, TX.
Affected count
25 units
Manufactured in
3773 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
For intraventricular indications mainly used for operations within the brain ventricles. Product Code: FF399R
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2518-2023Don't want to check this manually?
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