FDA Device recall Z-1007-2017
AxIEM Touch N Go Pointer Probe
- FDA Device
- Class II
- terminated
- Published 2017-01-18
On 2017-01-18 the FDA classified a Class II recall of AxIEM Touch N Go Pointer Probe by Medtronic Navigation, citing medtronic Navigation, Inc. announces a voluntary field action for the AxIEM Touch N Go Pointer Probe because the patient registration accuracy may compromise navigation accuracy w….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1007-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-12-12 |
| Published | 2017-01-18 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Medtronic Navigation |
| Distribution | US |
Product
AxIEM Touch N Go Pointer Probe. Model Number: 9735318. Placed in a 30mil PETG tray sealed with a Tyvek lid and then placed in a shelf carton.
Reason
Medtronic Navigation, Inc. announces a voluntary field action for the AxIEM Touch N Go Pointer Probe because the patient registration accuracy may compromise navigation accuracy when using the StealthStation¿ System with Touch N Go Pointer Probes for patient registration.
Identifiers
| code_info | lot number 150626B |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Other recalls by Medtronic Navigation
- Medtronic PIN, 100mm STERILE PERCUTANEOUS REF: 9733235 Medtronic PIN, 150MM, STERILE PERCUTANEOUS REF: 97733236 The Sterile Percutaneous Re…
FDA Device · Class II · 2025-02-05 · Medtronic Navigation - StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762) The StealthStation System, with StealthStation Spine software, is intende…
FDA Device · Class II · 2024-10-16 · Medtronic Navigation - Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only
FDA Device · Class I · 2024-05-15 · Medtronic Navigation - Medtronic, REF 9733235, Pin, 100mm, STERILE, PERCUTANEOUS
FDA Device · Class II · 2024-01-17 · Medtronic Navigation - Medtronic, REF 9733236, Pin, 150mm, STERILE, PERCUTANEOUS
FDA Device · Class II · 2024-01-17 · Medtronic Navigation
All Medtronic Navigation recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1007-2017%22
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