Z-2330-2020Class II

Mazor X Surgical System Positioner Type II, REF: ASM0214-02

Name: Z-2330-2020 Mazor X Surgical System Positioner Type II, REF: ASM0214-02
Creator: Medtronic Navigation, Inc.
Published: 2019-12-05
License: https://open.fda.gov/license/

Medtronic Navigation, Inc / initiated 2019-12-05 / Open, Classified / root cause: design

FDA source

Medtronic Navigation, Inc. began a recall of Mazor X Surgical System Positioner Type II, REF: ASM0214-02 on 2019-12-05. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2330-2020
Classification: Class II
Status: Open, Classified
Initiated: 2019-12-05
Posted: 2020-06-09
Recalling firm: Medtronic Navigation, Inc
Product: Mazor X Surgical System Positioner Type II, REF: ASM0214-02
Product code: OLO Orthopedic Stereotaxic Instrument
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)]
Root cause tag: design
FDA root cause: Device Design
Action: The firm originally sent a "Medical Device Correction " letter to affected consignees on December 5, 2019. On November 9, 2020, a "Update - Medical Device Correction" letter was sent out to all affected customers. The purpose of the letter was to update consignees that since the initiation of the recall (12/5/2019), Medtronic had developed a fix to permanently correct the issue associated with the Mazor X Surgical system. The notice further stated that upon availability of parts, Medtronic will schedule a service visit to correct the system at no charge. Medtronic expects to initiate these service visits within the next six months. Pending completion of service to correct the Positioner Type II system, continue to follow the modified mounting instructions. The firm requested that consignees do the following: 1. Please sign and date the Customer Confirmation Form enclosed with this letter to confirm that you have reviewed the information included in this notification with all users of the affected Mazor X" Surgical System, including physician users. 2. Return the form to Medtronic via email at [email protected] or via fax at 651-367-7075 within 30 days of receipt. 3. If you have any questions regarding this notification, please contact Medtronic at 1-888-826-5603. Medtronic will initiate service visits to correct systems on-site at customer locations when the kits become available. This is expected to begin by February 2021. View spreadsheet for updated
Quantity in commerce: 177 Systems
Distribution: US: ALAR,AZ,CA,CO,CT,FL,GA,IA,ID,IL,IN,KY,MA,MI,MN,MO,NC,ND,NL,NY,OH,PA,SC,TN,TX,UT,VA,WA,WI,WV, OUS: Australia, China, India, Israel, Romania, Singapore, Thailand, United Kingdom, Switzerland, Spain, Germany, Belgium,
Product codes and lots: All Lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2330-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2330-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-06-17	2020-06-09

Product code OLO

K182077Class IIMazor X System (Mazor X Stealth Edition)Mazor Robotics , Ltd. / cleared 2018-11-02

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)