Recall Z-1234-2016— Medtronic Navigation, Inc.

Name: FDA recall Z-1234-2016
Creator: U.S. Food and Drug Administration
Published: 2016-02-22

Class II · Terminated

Class II FDA medical device recall by Medtronic Navigation, Inc., initiated 2016-02-22, terminated 2016-06-15. It names one FDA 510(k) clearance: K003201. Product: 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: Medtronic Navigation is recalling the Biotex Adapter Kit because it was commercially distributed by BioTex without a cleared premarket [510(k)] from FDA..

Recalling firm: Medtronic Navigation, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-02-22
Terminated: 2016-06-15
Firm location: Louisville, CO, United States

510(k) clearances named in this recall

1 on FDA's record

K003201 — STEALTHSTATION TREATMENT GUIDANCE PLATFORMMedtronic Surgical Navigation Technologies·cleared 2000-12-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.