PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: March 30, 2016 Initiated: February 22, 2016 #Z-1234-2016

Product Description

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.

Reason for Recall

Medtronic Navigation is recalling the Biotex Adapter Kit because it was commercially distributed by BioTex without a cleared premarket [510(k)] from FDA.

Details

Units Affected
4
Distribution
US Distribution to states of: FL, NJ, AZ, and NC.
Location
Louisville, CO

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Medtronic Navigation, Inc.. Units affected: 4.
Why was this product recalled? ▼
Medtronic Navigation is recalling the Biotex Adapter Kit because it was commercially distributed by BioTex without a cleared premarket [510(k)] from FDA.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 30, 2016. Severity: Moderate. Recall number: Z-1234-2016.

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