FDAFDA · Food and drugs·Recall number 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
Published April 23, 2014 · Recall initiated: November 18, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Brainlab AG
- Distributor
- 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 Republic, France, Germany, Italy, Japan, Malaysia, Netherlands, Norway, Philippines, Poland, Russian Federation, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey and United Kingdom.
- Lot
- Catalog Number: 22264; Serial Numbers: 000000000038012001 , 000000000060912001 , 000000000189912001 , 000000000224912001 , 000000000235512001 , 000000000282912001 , 000000000313612001 , 000000000319412001 , 000000000351112001 , 000000000356912001 , 000000000367212001 , 000000000433712001 , 000000000482012001 , 000000000502812001 , 000000000645612001 , 000000000731112001 , 000000000837312001 , 000000000898312001 , 000000000956812001 , 000000000998412001 , 000000001012812001 , 000000001105412001 , 000000001231812001 , 000000001353512001 , 000000001355412001 , 000000001433712001 , 000000001473712001 , 000000001493512001 , 000000001493712001 , 000000001566212001 , 000000001579112001 , 000000001635112001 , 000000001758212001 , 000000001770212001 , 000000001789312001 , 000000001868312001 , 000000001895412001 , 000000001909912001 , 000000002036112001 , 000000002309812001 , 000000002439112001 , 000000002468312001 , 000000002503012001 , 000000002573012001 , 000000002682913001 , 000000003000913001 , 000000003053313001 , 000000003066813001 , 000000003071613001 , 000000003087613001 , 000000003109513001 , 000000003109613001 , 000000003230113001 , 000000003246713001 , 000000003304113001 , 000000003331913001 , 000000003379313001 , 000000003453413001 , 000000003453513001 , 000000003622213001 , 000000003671813001 , 000000003744413001 , 000000003758413001 , 000000003819613001 , 000000003824913001 , 000000003866013001 , 000000003937813001 , 000000004094013001 , 000000004147413001 , 000000004356413001 , 000000004404013001 , 000000004489313001 , 000000004489413001 , 000000004505313001 , 000000004821913001 , 000000004882013001 , 000000004905013001 , 000000005396313001 , 000000005407413001 , 000000005505113001 , 000000005506013001 , 000000005531913001 , 000000005552313001 , 000000005578713001 , 000000005659713001 , 000000005702513001 , 000000005788213001 , 000000005817113001 , 000000005904513001 , 000000005904613001 , 000000005904713001 , 000000005904813001 , 000000005946713001 , 000000006046413001 , 000000006046513001 , 000000006096913001 , 000000006136313001 , 000000006233113001 , 000000006296713001 , 000000006426913001 , 000000006427213001 , 000000006621613001 , 000000006621613002 , 000000006656613001 , 000000006792613001 , 000000006833413001 , 000000006839413001 , 000000006998813001 , 000000007000113001 , 000000007122113001 , 000000007172913001 , 000000007405013001 , 000000007588513001 , 000000007637114001 , 000000007679714001 , 000000007698714001 , 000000007784614001 , 000000007859414001 , 000000007906314001 , 000000008020214001 , 000000008031314001 , 000000008184514001 , 000000008193214001 , 000000008199814001 , 000000008214014001 , 000000008259514001 , 000000008383314001 , 000000009718312001 , 000000009720812001 , 000000009781112001 , 000000009802512001 , 000000009901612001 , 000000009983912001
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Germany
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.