Brainlab AG: Medical Device Recall in 2014 - (Recall #: Z-1469-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

Brainlab, Spine & Trauma 3D 2.0, Navigation Software. An intraoperative image-guided localization system to enable minimally invasive surgery. Catalog Number: 22264

Product Classification:

Class II

Date Initiated: November 18, 2013

Date Posted: April 23, 2014

Recall Number: Z-1469-2014

Event ID: 67569

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

Status: Terminated

Product Quantity: 133 units

Code Information:

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

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated