Food, drugs, devices › Brainlab AG
Device recall: Brainlab, Spine & Trauma 3D 2.0, Navigation Software. An intraoperative image-guided localization system to enable minim
Brainlab AG (Feldkirchen, N/A) initiated this device recall on 18 Nov 2013; FDA lists 1 product record under event 67569, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 90% of the 1,236 device enforcement events initiated in 2013 carry the same class.
Status: Terminated, terminated 17 Jul 2017. Initiation: voluntary: firm initiated. Brainlab AG has 36 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Brainlab AG, Feldkirchen, N/A, Germany.
Reason for recall
"The "fluoro match registration" function of the Navigation Software Spine & Trauma 3D 2.0 allows the user to intraoperatively match e.g., CT data sets to the current patient anatomy visible on fluoroscopic images, used by the navigation software during spinal surgeries to display the position and orientation of instruments. For this registration function in combination with a digitally integrated"
Distribution
"Worldwide Distribution - US Distribution including the states of AZ, CA,GA, IL, IN, LA, MA, MI, NY, NC, OH, PA, TN, TX and WI and the countries of Australia, Austria, Belgium, Brazil, Chile, Czech…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1469-2014 | Brainlab, Spine & Trauma 3D 2.0, Navigation Software. An intraoperative image-guided localization system to enable minimally invasive surgery. Catalog Number: 22264 | 133 units | Class II | Terminated | 23 Apr 2014 |
Context
Other enforcement events for Brainlab AG
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "The "fluoro match registration" function of the Navigation Software Spine & Trauma 3D 2.0 allows the user to intraoperatively match e.g., CT data sets to the current patient anatomy visible on fluoroscopic images, used by the navigation software during spinal surgeries to display the position and orientation of instruments. For this registration function in combination with a digitally integrated"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution - US Distribution including the states of AZ, CA,GA, IL, IN, LA, MA, MI, NY, NC, OH, PA, TN, TX and WI and the countries of Australia, Austria, Belgium, Brazil, Chile, Czech…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 17 Jul 2017. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.