Recall Z-2330-2020 ยท OLO Orthopedic Stereotaxic Instrument
Medtronic Navigation, Inc.
Mazor X Surgical System Positioner Type II, REF: ASM0214-02
| Date | Jun 9, 2020 (initiated Dec 5, 2019) |
| Status | Open, Classified |
| 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 |
| 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K182077 | Mazor X System (Mazor X Stealth Edition) Mazor Robotics , Ltd., Nov 2, 2018 |