BioTex Reusable Adapter Kit recalled over sterility concerns

Recall date

February 22, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Medtronic Navigation, Inc. recalls BioTex Reusable Adapter Kit, Part Number 401-021-1010, packaged non-sterile in a dedicated case for steam sterilization…

Recall number

Z-1234-2016

FDA classification

Class II

Brand / firm

Medtronic Navigation, Inc.

Sold / distributed

US Distribution to states of: FL, NJ, AZ, and NC.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What 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.