CLASS II Device recall · Reported 17 Jan 2018 · FDA Enforcement Report

Navigation System Spine & Trauma 3D recalled by Brainlab AG

Brainlab is recalling Navigation System Spine & Trauma 3D with component Brainlab DrapeLink Registration Kit, distributed in Kansas. The recall was initiated on 16 Nov 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel No. 19154, UDI GTIN 04056481132187. Model No. 19154-04, UDI No. GTIN 04056481113926. Serial No. range 7459316001 - 7459316027 and 7714816001 - 7714816017.

Quantity recalled80 devices total

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-0320-2018
FDA event ID: 78715
Recalling firm: Brainlab, Munich, N/A
Classification: Class II
Status: Terminated
Recall initiated: 16 Nov 2017
FDA classified: 5 Jan 2018
Reported: 17 Jan 2018
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Spinal Implants

Timeline

16 Nov 2017	Recall initiated by company
5 Jan 2018	Classified by FDA	+50 days
17 Jan 2018	Published in enforcement report	+12 days

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

Reason for recall

Due to a human error at a supplier, an unknown number of devices within one specific production lot of Brainlab DrapeLink Adapters (Left/Right) were not manufactured according to defined specifications.

Product as listed by the FDA

Brainlab Navigation System Spine & Trauma 3D with component Brainlab DrapeLink Registration Kit for C-arm Zeihm Vision RFD: Adapter Left

Where it was distributed

Distributed in the US to Kansas. Distributed internationally to Australia, Finland, France, Germany, Hong Kong, Ireland, Japan, Netherlands, Norway, Sweden, Switzerland, Taiwan, Turkey, United Kingdom.

Kansas

Questions about this recall

Why was it recalled?

Which lots are affected?

Model No. 19154, UDI GTIN 04056481132187. Model No. 19154-04, UDI No. GTIN 04056481113926. Serial No. range 7459316001 - 7459316027 and 7714816001 - 7714816017.

Where was it sold?

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.

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