Reported Sep 25, 2024 · Ongoing
Mazor X. Model Number REF TPL0059; stereotaxic orthopedic instrument
Mazor Robotics Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Mazor Robotics Ltd · North Industrial Park · Caesarea · N/A
Is this the product you have?
- Mazor X. Model Number REF TPL0059; stereotaxic orthopedic instrument
- Lot codes and dates
4 of 4 products
Products covered by this recall # Barcodes Product as published 1 07290109180465UDI/DI 07290109180465, Lot Numbers: 400-38-122016, 400-44-022017, 400-67-062017, 400-69-062017 2 07290109181158UDI/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 3 07290109184098UDI/DI 07290109184098, Lot Numbers: 4003840821, 4003860821, 4004151121, 4004231221, 4004290122, 4004310122 4 07290115751376UDI/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 - Amount recalled
- 94 devices
Where it was sold
- Nationwide
- PR
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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