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U.S. Department of Health and Human Services

Class 2 Device Recall Mazor X System (Mazor X Stealth Edition)

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  Class 2 Device Recall Mazor X System (Mazor X Stealth Edition) see related information
Date Initiated by Firm December 05, 2019
Date Posted June 09, 2020
Recall Status1 Open3, Classified
Recall Number Z-2330-2020
Recall Event ID 85387
510(K)Number K182077  
Product Classification Orthopedic stereotaxic instrument - Product Code OLO
Product Mazor X Surgical System Positioner Type II, REF: ASM0214-02
Code Information All Lots
Recalling Firm/
Manufacturer		 Medtronic Navigation, Inc.
826 Coal Creek Cir
Louisville CO 80027-9710
For Additional Information Contact Medtronic
188-826-5303
Manufacturer 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)]
FDA Determined
Cause 2		 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 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,
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = OLO and Original Applicant = Mazor Robotics Ltd.
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