Recall Z-2330-2020— Medtronic Navigation, Inc.

Name: FDA recall Z-2330-2020
Creator: U.S. Food and Drug Administration
Published: 2019-12-05

Class II · Ongoing

Class II FDA medical device recall by Medtronic Navigation, Inc., initiated 2019-12-05. It names one FDA 510(k) clearance: K182077. Product: Mazor X Surgical System Positioner Type II, REF: ASM0214-02. 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)].

Recalling firm: Medtronic Navigation, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2019-12-05
Firm location: Louisville, CO, United States

510(k) clearances named in this recall

1 on FDA's record

K182077 — Mazor X System (Mazor X Stealth Edition)Mazor Robotics , Ltd.·cleared 2018-11-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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)]

Data sourced from openFDA. This site is unofficial and independent of the FDA.