Medtronic Navigation, Inc.: Medical Device Recall in 2016 - (Recall #: Z-1234-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: February 22, 2016

Date Posted: March 30, 2016

Recall Number: Z-1234-2016

Event ID: 73337

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.

Status: Terminated

Product Quantity: 4

Code Information:

The adapter kits are not identified with any lot/code numbers. The BioTex Adapter kits were manufactured between 2008 and 2010.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated