BioTex Reusable Adapter Kit — Class II medical device recall Z-1234-2016
Terminated recall by Medtronic Navigation, Inc., reported 2016-03-30, distributed in AZ, FL, NC, NJ. Medtronic Navigation is recalling the Biotex Adapter Kit because it was commercially distributed by BioTex wit
| Recall number | Z-1234-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Navigation, Inc., Louisville, CO, United States |
| Recall initiated | 2016-02-22 |
| Classified | 2016-03-23 |
| Reported by FDA | 2016-03-30 |
| Terminated | 2016-06-15 |
| Distributed | AZ, FL, NC, NJ |
| Quantity | 4 |
| Reason classes | unapproved product |
| Model numbers | 401-021-1010 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1234-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.