Medtronic recalls Mazor X Surgical System Positioner Type II (REF: ASM0214-02) due to potential detachment from the operating table, which could fall on a patient causing injury.
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)]
Medtronic is recalling its Mazor X Surgical System Positioner Type II model because it might detach from the operating table and fall on a patient, causing injury like bleeding or fractures. This is a serious risk during surgery.
The surgical system could detach unexpectedly from the operating table. If it falls, it might hit the patient directly, causing bleeding, bruising, or fractures. This risk occurs during surgery when the device is in use.
Surgical teams using the Mazor X Surgical System Positioner Type II during operations are affected. Patients at risk include those undergoing surgery with this device attached to their operating table.
Check for the Mazor X Surgical System Positioner Type II model with reference number ASM0214-0: All lots are affected. This device is used in operating rooms during surgical procedures.
Immediately stop using the Mazor X Surgical System Positioner Type II (REF: ASM0214-02) as it could detach and fall on a patient.
No, Medtronic has recalled this device due to a risk of detaching and falling on patients during surgery.
Look for the Mazor X Surgical System Positioner Type II with reference number ASM0214-02; all lots are affected.
Immediately stop using it and contact Medtronic for further instructions.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-2330-2020 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-2330-2020 from Medtronic. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
