CLASS II Device recall · Reported 24 Mar 2021 · FDA Enforcement Report

Impactis NaviKit-stereotaxic accessory recalled by Imactis

Imactis is recalling Impactis NaviKit-stereotaxic accessory for Computed Tomography systems Reference # I10100, distributed in New Jersey, New York, Wisconsin. The recall was initiated on 11 Feb 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLots #: 20060001, 20060005 UDI-DI: B681I101002

Quantity recalled105 kits

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1264-2021
FDA event ID: 87391
Recalling firm: Imactis, St Martin D Heres, N/A
Classification: Class II
Status: Terminated
Recall initiated: 11 Feb 2021
FDA classified: 16 Mar 2021
Reported: 24 Mar 2021
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Labeling Errors
Device type: Other Medical Devices

Timeline

11 Feb 2021	Recall initiated by company
16 Mar 2021	Classified by FDA	+33 days
24 Mar 2021	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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

Product as listed by the FDA

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

Where it was distributed

NJ, NY, WI

New Jersey New York Wisconsin

Questions about this recall

Why was it recalled?

Which lots are affected?

Lots #: 20060001, 20060005 UDI-DI: B681I101002

Where was it sold?

NJ, NY, WI

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Imactis

All 3

Reported	Class	Recall	Company	Reason	Where
23 Sep 2020Device	CLASS II	Patient Fiducial (Patient Referential) recalled by Imactis	Imactis	Other	Nationwide
29 Jan 2020Device	CLASS II	Navigation Kit recalled by Imactis	Imactis	Sterility	IL, WI

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