FDA recall Z-1264-2021

Product

Impactis NaviKit-stereotaxic accessory for Computed Tomography systems Reference # I10100

Reason for recall

Defect in the mechanical assembly of the needle holder contained in the navigation kit. One of the 2 jaws of the needle holder does not provide gripping functionality; if the defect is not detected before use, it can cause poor needle guidance and a lack of precision during navigation causing an inaccurate needle position which could cause damage to organs or vasculature adjacent to the trajectory

Distribution

NJ, NY, WI

Key facts

Status

Terminated

Initiation date

2021-02-11

Report date

2021-03-24

Termination date

2023-10-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

St Martin D Heres, N/A, France

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1264-2021