FDA Device recall Z-2330-2020
Mazor X Surgical System Positioner Type II, REF: ASM0214-02
- FDA Device
- Class II
- ongoing
- Published 2020-06-17
On 2020-06-17 the FDA classified a Class II recall of Mazor X Surgical System Positioner Type II, REF: ASM0214-02 by Medtronic Navigation, citing there is a potential for the surgical system to detach from the operational room table unexpectedly. This could result in the surgical system falling onto the patient resulting in….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2330-2020 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2019-12-05 |
| Published | 2020-06-17 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Medtronic Navigation |
| Distribution | AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, MA, MI, MN, MO, NC, ND, NY, OH, PA, SC, TN, TX, UT, VA, WA, WI, WV |
Product
Mazor X Surgical System Positioner Type II, REF: ASM0214-02
Reason
There is a potential for the surgical system to detach from the operational room table unexpectedly. This could result in the surgical system falling onto the patient resulting in blunt injury [hemorrhage, hematoma, bleeding, or fracture(s)]
Identifiers
| code_info | All Lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
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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-2330-2020%22
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