Mazor Robotics recalls Mazor X model REF TPL0059 stereotaxic orthopedic instruments with software anomalies that could cause navigation mismatches during surgery. Affected units have specific UDI/DI numbers and lot ranges.
Software anomalies which can result in two separate issues: A lagging screen display during a navigated procedure; or the potential for a mismatch between the navigated screw and the screw information presented on the screen.
Mazor Robotics is recalling certain Mazor X stereotaxic orthopedic instruments due to software issues that might cause navigation errors during surgical procedures. This could lead to incorrect screw placement if the system's display lags or mismatches the actual screw position with what's shown on screen.
The software anomalies can cause the surgical navigation screen to lag during procedures or mismatch the actual screw position with what's displayed on screen. This could lead to incorrect screw placement if the surgeon relies on the system's guidance.
Surgical teams using Mazor X instruments with specific UDI/DI numbers and lot ranges (listed in the recall) are most at risk. Patients undergoing orthopedic surgery with these instruments may face potential navigation errors.
Check for UDI/DI numbers starting with 0729010918 and lot numbers in the specific ranges listed in the recall notice. The affected instruments are stereotaxic orthopedic surgical tools used in procedures like spinal or joint surgery.
Review your instrument's UDI/DI number and lot numbers against the list provided in the recall notice to confirm if it's affected.
Mazor Robotics recalls these instruments due to software anomalies that could cause navigation mismatches during surgical procedures, potentially leading to incorrect screw placement.
Check your instrument's UDI/DI number and lot numbers against the specific ranges listed in the recall notice (e.g., UDI/DI 07290109180465 with lot numbers 400-38-122016 through 400-69-062017).
If your instrument's UDI/DI and lot numbers don't match the affected ranges, no action is required.
We’ve drafted a message you can send Mazor Robotics to request your refund or repair — edit it as you like.
Subject: Recall Z-3156-2024 — Mazor Robotics Mazor Robotics Hello, I own a Mazor Robotics that is covered by recall Z-3156-2024 from Mazor Robotics. 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.
