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Open, Classified

Mazor X. Model Number REF TPL0059; stereotaxic orthopedic instrument

FDA Recall Z-3156-2024 · Posted 2024-09-16

Recalling FirmMazor Robotics Ltd
Recall StatusOpen, Classified
Product CodeOLO
Date Initiated2024-07-17
Product Quantity94 devices

Reason for Recall

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.

Firm Action

Medtronic/Mazor Robotics, Ltd. issued an URGENT: Medical Device Software Correction to its consignees on 07/17/2024 via 2-day tracked mailing. The notice explained the issue, potential risk, and provided a workaround until the software update is installed. Medtronic will schedule a time to perform a software update that will resolve these anomalies. Medtronic field service engineers will update all Mazor X systems from version 5.1.1 to version 5.1.2 or later. Questions: contact Medtronic Technical Services at 1-888-826-5603 or [email protected] .

Root Cause

Device Design

Distribution Pattern

US Nationwide distribution in PR.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K230064Mazor X System (Mazor X Stealth Edition)Mazor Robotics , Ltd. · 2023-04-07

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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