FDA recall Z-2518-2023

Product

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

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.

Key facts

Status

Ongoing

Initiation date

2023-07-20

Report date

2023-09-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Center Valley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2518-2023