Mazor X Surgical System Positioner Type II — Class II medical device recall Z-2330-2020
Ongoing recall by Medtronic Navigation, Inc., reported 2020-06-17, distributed in AZ, CA, CO, CT, FL, GA, IA, ID…. There is a potential for the surgical system to detach from the operational room table unexpectedly. This coul
| Recall number | Z-2330-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Navigation, Inc., Louisville, CO, United States |
| Recall initiated | 2019-12-05 |
| Classified | 2020-06-09 |
| Reported by FDA | 2020-06-17 |
| Distributed | 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 |
| Countries outside the US | AU, BE, CH, CN, DE, ES, GB, IL, IN, RO, SG, TH |
| Quantity | 177 systems |
| Reason classes | device malfunction |
| Model numbers | ASM0214-02 |
Product
Mazor X Surgical System Positioner Type II, REF: ASM0214-02
Reason for recall
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)]
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-2330-2020. 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.