Impactis NaviKit-stereotaxic accessory for Computed Tomography… — Class II medical device recall Z-1264-2021
Terminated recall by Imactis, reported 2021-03-24, distributed in NJ, NY, WI. Defect in the mechanical assembly of the needle holder contained in the navigation kit. One of the 2 jaws of t
| Recall number | Z-1264-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Imactis, St Martin D Heres, N/A, France |
| Recall initiated | 2021-02-11 |
| Classified | 2021-03-16 |
| Reported by FDA | 2021-03-24 |
| Terminated | 2023-10-05 |
| Distributed | NJ, NY, WI |
| Quantity | 105 kits |
| Lot numbers | 20060001, 20060005 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1264-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.