Z-1264-2021 Class II Terminated
FDA device recall Z-1264-2021 was initiated by Imactis on February 11, 2021 and is designated Class II. 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 be… The recall status is terminated (terminated October 5, 2023). Affected quantity: 105 kits.
Recall Details
- Product Type
- Devices
- Report Date
- March 24, 2021
- Initiation Date
- February 11, 2021
- Termination Date
- October 5, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 105 kits
Product Description
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 Pattern
NJ, NY, WI
Code Information
Lots #: 20060001, 20060005 UDI-DI: B681I101002