FDA Medical Device Recalls (openFDA)
Medtronic Navigation, Inc.: Mazor X Surgical System Positioner Type II, REF: ASM0214-02
- Recall number
- Z-2330-2020
- Recalling firm
- Medtronic Navigation, Inc.
- Product
- Mazor X Surgical System Positioner Type II, REF: ASM0214-02
- Status
- Open, Classified
- Initiated
- 2019-12-05
- Posted
- 2020-06-09
- Terminated
- not on file
- 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)]
- 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 RS.NavFCA@Medtronic.com 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
- 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,
- Lot, serial or model codes
- All Lots
- 510(k) numbers
- ["K182077"]
- PMA numbers
- not on file
- Product code
- OLO
- Firm FEI
- 1000517638
- Firm city
- Louisville
- Firm state
- CO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28