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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Mazor Robotics Ltd: Mazor X Orthopedic Instrument Recalled for Software Display Anomalies

Agency Publication Date: September 16, 2024
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Summary

Mazor Robotics Ltd is recalling 94 units of the Mazor X (Model REF TPL0059) stereotaxic orthopedic instrument due to software errors. These anomalies can cause the screen to lag during navigated surgery or display incorrect information that does not match the actual screw being used. The firm initiated this voluntary recall via letter to ensure healthcare providers are aware of these critical navigation issues. If you or a family member have a surgery scheduled using this device, you should contact your surgical team or healthcare provider to discuss the status of the equipment.

Risk

A lagging display or a mismatch between the navigated screw and the information on the screen can cause a surgeon to place surgical hardware inaccurately. This poses a risk of incorrect screw placement, which could lead to nerve damage, vascular injury, or the need for additional corrective surgery.

What You Should Do

  1. Identify if your facility's Mazor X system is affected by checking for Model Number REF TPL0059 and matching the Lot Numbers listed in the product details.
  2. Check your device for UDI/DI 07290109180465 with Lot Numbers 400-38-122016, 400-44-022017, 400-67-062017, or 400-69-062017.
  3. Check your device for UDI/DI 07290109181158 with Lot Numbers including 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, or 4004091121.
  4. Check your device for UDI/DI 07290109184098 with Lot Numbers 4003840821, 4003840821, 4003860821, 4004151121, 4004231221, 4004290122, or 4004310122.
  5. Check your device for UDI/DI 07290115751376 with Lot Numbers including 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, or 4006800823.
  6. Healthcare providers and hospital staff should contact Mazor Robotics Ltd at their Caesarea, Israel office or through their local Medtronic/Mazor representative for software update instructions and support.
  7. If you are a patient, contact your surgeon or healthcare provider to confirm if this device was or will be used in your procedure and to address any safety concerns.
  8. For further information or to report problems, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer Notification and Correction

How to: Contact your healthcare provider or the manufacturer for further instructions regarding software corrections and potential system updates.

Affected Products

Product: Mazor X Stereotaxic Orthopedic Instrument
Model / REF:
REF TPL0059
UPC Codes:
07290109180465
07290109181158
07290109184098
07290115751376
Lot Numbers (94):
400-38-122016
400-44-022017
400-67-062017
400-69-062017
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

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95189
Status: Active
Manufacturer: Mazor Robotics Ltd
Sold By: Authorized Medical Distributors; Medtronic
Manufactured In: Israel
Units Affected: 94 devices
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.