CLASS II Device recall · Reported 19 Aug 2020 · FDA Enforcement Report

Brainlab Kick 2; Model/catalogue (article) numbers for Kick recalled

Brainlab AG is recalling Brainlab Kick 2, distributed in California, Rhode Island, Texas. The recall was initiated on 16 Jul 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesKICK 2 NAVIGATION STATION, Serial Numbers: 0164217001-18170, S/N of affected NDI Camera: P7-12520 2703119001-18170, S/N of affected NDI Camera:P7-20938 2933119001-18170, S/N of affected NDI Camera:P7-21378 6171619001-18170, S/N of affected NDI Camera:P7-18830 8745417001-18170, S/N of affected NDI Camera:P7-15162 9178819001-18170, S/N of affected NDI Camera:P7-16025 9607118001-18170, S/N of affected NDI Camera:P7-13227 5469918001-18170, S/N of affected NDI Camera: P7-14965 KICK NAVIGATION STATION, Serial Number: 1190017001-18070, S/N of affected NDI Camera: P7-06110

Quantity recalled9 unit

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-2793-2020
FDA event ID: 86046
Recalling firm: Brainlab AG, Munich, N/A
Classification: Class II
Status: Terminated
Recall initiated: 16 Jul 2020
FDA classified: 13 Aug 2020
Reported: 19 Aug 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

16 Jul 2020	Recall initiated by company
13 Aug 2020	Classified by FDA	+28 days
19 Aug 2020	Published in enforcement report	+6 days

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

Reason for recall

Incorrect manufacturer calibration

Product as listed by the FDA

BRAINLAB Kick 2; Model/catalogue (article) numbers for Kick: 18170; 18070 UDI (GTIN) for Kick: 04056481006655

Where it was distributed

USA: CA, TX, RI OUS: Armenia; Australia; Brazil; Bulgaria; Canada; Finland; France; Germany; Hong Kong; India; Israel; Italy; Japan; Mongolia; Morocco; Spain

California Rhode Island Texas

Questions about this recall

Is Brainlab Kick 2; Model/catalogue (article) numbers for Kick: 18170 recalled?

Yes. Brainlab AG recalled Brainlab Kick 2; Model/catalogue (article) numbers for Kick: 18170 on 16 Jul 2020. The recall is Class II and its status is Terminated. Recall number Z-2793-2020.

Why was it recalled?

Incorrect manufacturer calibration

Which lots are affected?

KICK 2 NAVIGATION STATION, Serial Numbers: 0164217001-18170, S/N of affected NDI Camera: P7-12520 2703119001-18170, S/N of affected NDI Camera:P7-20938 2933119001-18170, S/N of affected NDI Camera:P7-21378 6171619001-18170, S/N of affected NDI Camera:P7-18830 8745417001-18170, S/N of affected NDI Camera:P7-15162 9178819001-18170, S/N of affected NDI Camera:P7-16025 9607118001-18170, S/N of affected NDI Camera:P7-13227 5469918001-18170, S/N of affected NDI Camera: P7-14965 KICK NAVIGATION STATION, Serial Number: 1190017001-18070, S/N of affected NDI Camera: P7-06110

Where was it sold?

USA: CA, TX, RI OUS: Armenia; Australia; Brazil; Bulgaria; Canada; Finland; France; Germany; Hong Kong; India; Israel; Italy; Japan; Mongolia; Morocco; Spain

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

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