Mazor X. Model Number REF TPL0059; stereotaxic orthopedic... – software anomalies which can result i... (2024)
Software anomalies may cause display lag or potential mismatch of navigational information.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Mazor X. Model Number REF TPL0059; stereotaxic orthopedic instrument
Lot Codes / Batch Numbers
UDI/DI 07290109180465, Lot Numbers: 400-38-122016, 400-44-022017, 400-67-062017, 400-69-062017, UDI/DI 07290109181158, Lot Numbers: 4001200218, 4001970419, 4001011117, 4001041117, 4001061117, 4001320518, 4001330618, 4001390818, 4001430918, 4001631218, 4001690119, 4001710119, 4001780219, 4001790219, 4001800219, 4001960419, 4001980419, 4002050419R, 4002170619, 4002230819, 4002240819, 4002310919, 4002511119, 4002531119, 4002541119, 4002591119, 4002641219, 4002661219, 4002850220, 4002860220R, 4002900220, 4003020320, 4003030320, 4003180320, 4003190320, 4003430920, 4006951223, 4006901223, 4006890923, 4006860923, 4006830923, 4006680723, 4006170323, 4006090223, 4006050223, 4006040223, 4005210922, 4005770123, 4005720123, 4005431122, 4005750123, 4006130323, 4004091121, UDI/DI 07290109184098, Lot Numbers: 4003840821, 4003860821, 4004151121, 4004231221, 4004290122, 4004310122, UDI/DI 07290115751376, Lot Numbers: 4004860522, 4005180822, 4004670322, 4004700322, 4004870522, 4005080722, 4005130822, 4005340922, 4005401122, 4005421122, 4005451122, 4005481122, 4005491122, 4005591222, 4005760123, 4005790123, 4005870123, 4005900223, 4005910223, 4005940223, 4005980223, 4006030223, 4006140323, 4006230423, 4006330523, 4006630723, 4006660723, 4006670723, 4006740823, 4006790823, 4006800823
Products Sold
UDI/DI 07290109180465, Lot Numbers: 400-38-122016, 400-44-022017, 400-67-062017, 400-69-062017; UDI/DI 07290109181158, Lot Numbers: 4001200218, 4001970419, 4001011117, 4001041117, 4001061117, 4001320518, 4001330618, 4001390818, 4001430918, 4001631218, 4001690119, 4001710119, 4001780219, 4001790219, 4001800219, 4001960419, 4001980419, 4002050419R, 4002170619, 4002230819, 4002240819, 4002310919, 4002511119, 4002531119, 4002541119, 4002591119, 4002641219, 4002661219, 4002850220, 4002860220R, 4002900220, 4003020320, 4003030320, 4003180320, 4003190320, 4003430920, 4006951223, 4006901223, 4006890923, 4006860923, 4006830923, 4006680723, 4006170323, 4006090223, 4006050223, 4006040223, 4005210922, 4005770123, 4005720123, 4005431122, 4005750123, 4006130323, 4004091121; UDI/DI 07290109184098, Lot Numbers: 4003840821, 4003860821, 4004151121, 4004231221, 4004290122, 4004310122; UDI/DI 07290115751376, Lot Numbers: 4004860522, 4005180822, 4004670322, 4004700322, 4004870522, 4005080722, 4005130822, 4005340922, 4005401122, 4005421122, 4005451122, 4005481122, 4005491122, 4005591222, 4005760123, 4005790123, 4005870123, 4005900223, 4005910223, 4005940223, 4005980223, 4006030223, 4006140323, 4006230423, 4006330523, 4006630723, 4006660723, 4006670723, 4006740823, 4006790823, 4006800823
A medical device manufacturer is recalling Mazor X. Model Number REF TPL0059; stereotaxic orthopedic instrument due to Software anomalies which can result in two separate issues: A lagging screen display during a navigated procedure; or the potential for a mismatch bet. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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 rs.navtechsupport@medtronic.com .
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026