Mazor X System recallZ-0101-2024 · Mazor Robotics Ltd · initiated Sep 5, 2023
Open, Classified
Is my device affected?
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- If yours is listed, follow the instructions from Mazor Robotics Ltd or your healthcare provider. The company's action is summarized under what the company is doing.
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Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Software update
FDA root cause category: Software design
What the company is doing
IMazor Robotics, Ltd. issued an URGENT: Medical Devices Software Correction notice to its consignees on 09/05/2023 via 2-day tracked mailing and in Puerto Rico it was hand delivered by the regional field representative. The notice explained the anomalies to be corrected and the potential health hazards associated with the anomalies. Medtronic field service engineers will be updating all Mazor X" systems from version 4.2.2 or 5.0.1 to version 5.1.1 in the US at your next planned service visit, or earlier.
Recall details
- Recall number
- Z-0101-2024
- Status
- Open, Classified
- Initiated by the company
- Sep 5, 2023
- Posted by the FDA
- Oct 12, 2023
- Recalling firm
- Mazor Robotics Ltd
- Quantity
- 324 devices
- Product code
- OLO
- FDA submissions
- K203005
- Distribution
- US Nationwide distribution.
Product description
MAZOR X robotic guidance system, Model TPL0059, with software versions 4.2.2 or 5.0.1
Code information (models, lots, serial numbers)
Show the full code information (4k characters)
GTIN 07290109180465, Serial Numbers: 4000770717, 4000800717, 4000810817, 4000820817, 4000830817, 4000840817, 4000850817, 4000870817, 4000880817, 4000890917, 4000900917, 4000910917, 4000920917, 4000930917, 4000940917, 4000951017, 4000961017, 4000971017, 4000981017, 4000991017, 4001001017, 4001011117, 4001041117, 4001061117, 4001071217, 4001081217, 4001091217, 4001101217, 4001111217, 4001121217, 4001130118, 4001140118, 4001150118, 4001160118, 4001180118, 400-26-112016, 400-27-112016, 400-29-122016, 400-30-122016, 400-31-122016, 400-36-122016, 400-38-122016, 400-44-022017, 400-47-022017, 400-48-022017, 400-50-032017, 400-51-032017, 400-53-032017, 400-54-032017, 400-55-032017, 400-56-032017, 400-59-052017, 400-60-052017, 400-61-062017, 400-63-062017, 400-64-062017, 400-65-062017, 400-67-062017, 400-68-062017, 400-69-062017, 400-71-062017, 400-72-062017, 400-73-062017, 400-75-062017, 400-78-072017, 400-79-072017; GTIN 07290109181158, Serial Numbers: 4001200218, 4001210218, 4001270318, 4001280318, 4001300518, 4001310518, 4001320518, 4001330618, 4001360618, 4001370718, 4001390818, 4001400818, 4001410918, 4001430918, 4001440918, 4001450918, 4001470918, 4001481018, 4001501018, 4001511018, 4001521118, 4001531118, 4001541118, 4001551118, 4001561118, 4001571118, 4001601218, 4001611218, 4001631218, 4001641218, 4001651218, 4001680119, 4001690119, 4001710119, 4001740219; GTIN 07290109183213, Serial Numbers: 4001770219, 4001780219, 4001790219, 4001800219, 4001820219, 4001840219, 4001850219, 4001900319, 4001920419, 4001940419, 4001960419, 4001970419, 4001980419, 4001990419, 4002000419, 4002010419, 4002020419, 4002060519, 4002070519, 4002080519, 4002090519, 4002100519, 4002140619, 4002150619, 4002160619, 4002170619, 4002180619, 4002220719, 4002230819, 4002240819, 4002250819, 4002260819, 4002270819, 4002280819, 4002290819, 4002300819, 4002310919, 4002330919, 4002340919, 4002350919, 4002360919, 4002370919, 4002380919, 4002390919, 4002400919, 4002411019, 4002421019, 4002441019, 4002451019, 4002461019, 4002511119, 4002531119, 4002541119, 4002551119, 4002561119, 4002591119, 4002611219, 4002621219, 4002631219, 4002641219, 4002661219, 4002681219, 4002720120, 4002730120, 4002740120, 4002750120, 4002790120, 4002810120, 4002820120, 4002830220, 4002850220, 4002880220, 4002900220, 4002950220, 4002960220, 4002990220, 4003000320, 4003020320, 4003030320, 4003040320, 4003050320, 4003060320, 4003080320, 4003100320, 4003120320, 4003130320, 4003150320, 4003160320, 4003170320, 4003180320, 4003190320, 4003200320, 4003250520, 4003260520, 4003270520, 4003290520, 4003300620, 4003310520, 4003330620, 4003340620, 4003350620, 4003360620, 4003390820, 4003410920, 4003420920, 4003430920, 4003440920, 4003450920, 4003460920, 4003471120, 4003481120, 4003491120, 4003501120, 4003541120, 4003550121, 4003560121, 4003640221, 4003680421, 4003700521, 4003710621, 4003720521, 4003730621, 4003740621, 4003760621, 4003780621, 4003800821, 4003810821, 4003820821, 4003840821, 4003850821, 4003860821, 4003870821, 4003880821, 4003930921, 4003940921, 4003950921, 4003960921, 4003970921, 4003981021, 4003991021, 4004001021, 4004011021, 4004021021, 4004031021, 4004041021, 4004061121, 4004081121, 4004101121, 4004131121, 4004141121, 4004151121, 4004181221, 4004231221, 4004241221, 4004270122, 4004290122, 4004300122, 4004310122, 4004320122, 4004330122, 4004340122, 4004350122, 4004370122, 4004380122, 4004410222, 4004500322, 4004520322, 4004540322, 4004550322, 4004560322, 4004600322, 4004610322, 4004620322, 4004630322, 4004650322, 4004660322, 4004670322, 4002050419R, 4002860220R; GTIN 07290115751376, Serial Numbers: 4004680322, 4004700322, 4004710522, 4004790522, 4004810522, 4004830522, 4004870522, 4004910622, 4004950622, 4005030722, 4005080722, 4005130822, 4005140822, 4005150822, 4005200822, 4005210922, 4005220922, 4005230922, 4005240922, 4005250922, 4005290922, 4005330922, 4005340922, 4005350922, 4005360922, 4005401122, 4005431122, 4005451122, 4005471122, 4005481122, 4005501122, 4005521222, 4005551222, 4005561222, 4005571222, 4005621222, (new 04/11/2024): 4004251221, 4004440222, 4004930622, 4004980622, 4005491122, 4005960223, 4006070223, 4006750823
Devices named in this recall
4 devices in the FDA device registry whose identifier appears in the recall's code information.
- Mazor X System TPL0059-06Mazor Robotics Ltd · Orthopedic Stereotaxic Instrument2 recalls2 deaths392 reports
- Mazor X System TPL0059-09Mazor Robotics Ltd · Orthopedic Stereotaxic Instrument3 recalls1 death137 reports
- Mazor X System TPL0059-04Mazor Robotics Ltd · Orthopedic Stereotaxic Instrument3 recalls1 death131 reports
- Mazor X System TPL0059-05Mazor Robotics Ltd · Orthopedic Stereotaxic Instrument3 recalls65 reports
Product lines
Other devices under the same FDA submission
3 devices cleared under K203005 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Mazor X System TPL0059-08Mazor Robotics Ltd · Orthopedic Stereotaxic Instrument1 recall110 reports
- Mazor X System- Refurbished TPL0059-08RMazor Robotics Ltd · Orthopedic Stereotaxic Instrument1 recall18 reports
- Mazor X System- Refurbished TPL0059-06RMazor Robotics Ltd · Orthopedic Stereotaxic Instrument1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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