CLASS II ONGOING Device recall · Reported 25 Sep 2024 · FDA Enforcement Report
Mazor recalled by Mazor Robotics
Mazor Robotics is recalling Mazor X, distributed nationwide in the US. The recall was initiated on 17 Jul 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-3156-2024
- FDA event ID
- 95189
- Recalling firm
- Mazor Robotics, Caesarea
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 17 Jul 2024
- FDA classified
- 16 Sep 2024
- Reported
- 25 Sep 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Hip & Knee Implants
Timeline
| 17 Jul 2024 | Recall initiated by company | |
| 16 Sep 2024 | Classified by FDA | +61 days |
| 25 Sep 2024 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Mazor X. Model Number REF TPL0059; stereotaxic orthopedic instrument
Where it was distributed
US Nationwide distribution in PR.
Questions about this recall
Why was it 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.
Which lots are affected?
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
Where was it sold?
US Nationwide distribution in PR.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Mazor Robotics
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Mazor X robotic guidance system recalled by Mazor Robotics | Mazor Robotics | Device Malfunction | Nationwide |
| Device | CLASS II | Mazor X robotic guidance system recalled by Mazor Robotics | Mazor Robotics | Device Malfunction | Nationwide |
| Device | CLASS II | Snapshot Tracker Kit, Mas2659-01, KIT0898 recalled by Mazor Robotics | Mazor Robotics | Other | 26 states |
| Device | CLASS II | Carousel MAS1025-01, part of the Brain Surgical Accessories recalled | Mazor Robotics | Other |
Other Hip & Knee Implants recalls
All 3,111| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Intellijoint Navigation System: Workstation G2 Configured recalled | Intellijoint Surgical | Device Malfunction | Nationwide |
| Device | CLASS II | Trinity Non-Surgical Isolation Gown, AAMI PB70 Level 2, X-Large recalled | New York Embroidery Studio | Packaging Defects | Nationwide |
| Device | CLASS II | Axle Pin Assy Large Elbow Cobalt Chrome recalled by Howmedica Osteonics | Howmedica Osteonics | Other | Nationwide |
| Device | CLASS II | Triathlon Hinge Insert Size 4 5612-p-411 Triathlon Hinge recalled | Howmedica Osteonics | Other | Nationwide |
| Device | CLASS II | Scorpio Recessed Metal Backed Patella 3045 recalled | Howmedica Osteonics | Foreign Material | Nationwide |