Z-1234-2016Class II

BioTex Reusable Adapter Kit, Part Number 401-021-1010, packaged non-sterile in a dedicated case for steam...

Name: Z-1234-2016 BioTex Reusable Adapter Kit, Part Number 401-021-1010, packaged non-sterile in a dedicated case for steam...
Creator: Medtronic Navigation, Inc.
Published: 2016-02-22
License: https://open.fda.gov/license/

Medtronic Navigation, Inc / initiated 2016-02-22 / Terminated

FDA source

Medtronic Navigation, Inc. began a recall of 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... on 2016-02-22. FDA classified it as Class II and gives the reason as "Medtronic Navigation is recalling the Biotex Adapter Kit because it was commercially distributed by BioTex without a cleared premarket [510(k)] from FDA". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1234-2016
Classification: Class II
Status: Terminated
Initiated: 2016-02-22
Posted: 2016-03-24
Terminated: 2016-06-15
Recalling firm: Medtronic Navigation, Inc
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.
Product code: HAW Neurological Stereotaxic Instrument
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.
FDA root cause: No Marketing Application
Action: The firm, Medtronic, sent an "URGENT Medical Device Recall" letter dated 2/2016 to its consignees. The letter described the product, problem and actions to be taken. The identified consignees will be visited by the assigned Medtronic field representative to explain the need for the field action. The consignees are instructed to locate and remove/secure the kit from use. The Medtronic field representative will assist the consignee with identifying and removing the kit, and complete a Customer Visit record for each consignee they are assigned/visit to document the results of their visit. The consignee is instructed to sign the customer visit form presented by the representative. A copy of this record and a letter explaining the FCA will be left with the consignee. Please contact Medtronic Technical Services at 1-800-595-9709 if you have any questions regarding the subject action or the content of the letter.
Quantity in commerce: 4
Distribution: US Distribution to states of: FL, NJ, AZ, and NC.
Product codes and lots: The adapter kits are not identified with any lot/code numbers. The BioTex Adapter kits were manufactured between 2008 and 2010.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1234-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1234-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-30	2016-03-23

Product code HAW

K003201Class IIStealthstation Treatment Guidance PlatformMedtronic Surgical Navigation Technologies / cleared 2000-12-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)