Reported Oct 18, 2023 · Ongoing

MAZOR X robotic guidance system, Model TPL0059, with software versions 4.2.2 or 5.0.1

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 · N/A

Is this the product you have?

    • MAZOR X robotic guidance system
    • Model TPL0059
    • with software versions 4.2.2 or 5.0.1
Lot codes and dates
  • GTIN 07290109180465
  • Serial Numbers

    67 of 67 codes

    • 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
  • 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

    180 of 180 codes

    • 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
  • 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
Amount recalled
324 devices

Where it was sold

  • Nationwide

Why it was recalled

Software update

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:52 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.