FDA-Device2016-03-30Class II
BioTex Reusable Adapter Kit, Part Number 401-021-1010, packaged non-sterile in a dedicated case for steam sterilization The Adapter Kit is used during surgical procedures as an instrument guide holder that maintains the position of an instrument after they have been aligned by the physician via stereotactic guidance during planning and operation of neurological procedures performed in conjunction with the use of the Medtronic StealthStation Image Guided Workstation System.
Medtronic Navigation, Inc.
Hazard
Medtronic Navigation is recalling the Biotex Adapter Kit because it was commercially distributed by BioTex without a cleared premarket [510(k)] from FDA.
Sold states
US Distribution to states of: FL, NJ, AZ, and NC.
Affected count
4
Manufactured in
826 Coal Creek Cir, N/A, Louisville, CO, United States
Products
BioTex Reusable Adapter Kit, Part Number 401-021-1010, packaged non-sterile in a dedicated case for steam sterilization The Adapter Kit is used during surgical procedures as an instrument guide holder that maintains the position of an instrument after they have been aligned by the physician via stereotactic guidance during planning and operation of neurological procedures performed in conjunction with the use of the Medtronic StealthStation Image Guided Workstation System.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1234-2016Don't want to check this manually?
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