CLASS I Device recall · Reported 24 Apr 2019 · FDA Enforcement Report
Spine & Trauma 3D Navigation 0 (subpart of the system Navigation recalled
Brainlab AG is recalling Spine & Trauma 3D Navigation 0 (subpart of the system Navigation, distributed nationwide in the US. The recall was initiated on 27 Feb 2019 and the FDA has classified it as Class I.
Check your package
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-1082-2019
- FDA event ID
- 82304
- Recalling firm
- Brainlab AG, Munich, N/A
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 27 Feb 2019
- FDA classified
- 15 Apr 2019
- Reported
- 24 Apr 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Lead & Heavy Metals
- Device type
- Spinal Implants
Timeline
| 27 Feb 2019 | Recall initiated by company | |
| 15 Apr 2019 | Classified by FDA | +47 days |
| 24 Apr 2019 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
In certain occurrences, the affected navigation software application might unexpectedly display a navigated instrument in an axial, coronal/sagittal (ACS) view representation with fixed planes in the image reconstruction (the not-updated ACS view ), instead of displaying the desirable view representation Inline View , which is commonly used for navigating invasive instruments at the spine. This could lead the surgeon to be unable to determine the position of the navigated instrument. This might occur after a crash restore or after changing between different navigation workflows during the same patient treatment.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
Spine & Trauma 3D Navigation 1.0 (subpart of the system Navigation Software Spine & Trauma 3D, Version 3.0 ) Intended Use The Spine & Trauma Navigation System is intended as an intraoperative image-guided localization system to enable minimally invasive surgery.
Where it was distributed
Worldwide Distribution: US (Nationwide) and countries of: Australia, Austria, Belgium, Canada, Czech Republic, Denmark, Ecuador, France, Germany, Greece, Hong Kong, Ireland, Italy, Japan, Kazakhstan, Malaysia, New Zealand, Philippines, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand and United Kingdom.
Questions about this recall
Is Spine & Trauma 3D Navigation 0 (subpart of the system Navigation recalled?
Yes. Brainlab AG recalled Spine & Trauma 3D Navigation 0 (subpart of the system Navigation on 27 Feb 2019. The recall is Class I and its status is Terminated. Recall number Z-1082-2019.
Why was it recalled?
In certain occurrences, the affected navigation software application might unexpectedly display a navigated instrument in an axial, coronal/sagittal (ACS) view representation with fixed planes in the image reconstruction (the not-updated ACS view ), instead of displaying the desirable view representation Inline View , which is commonly used for navigating invasive instruments at the spine. This could lead the surgeon to be unable to determine the position of the navigated instrument. This might occur after a crash restore or after changing between different navigation workflows during the same patient treatment.
Which lots are affected?
Version 1.0.0.249, GTIN 04056481140328
Where was it sold?
Worldwide Distribution: US (Nationwide) and countries of: Australia, Austria, Belgium, Canada, Czech Republic, Denmark, Ecuador, France, Germany, Greece, Hong Kong, Ireland, Italy, Japan, Kazakhstan, Malaysia, New Zealand, Philippines, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand and United Kingdom.
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
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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