FDA Medical Device Recalls (openFDA)
Mazor Robotics Ltd: Mazor X. Model Number REF TPL0059; stereotaxic orthopedic instrument
- Recall number
- Z-3156-2024
- Recalling firm
- Mazor Robotics Ltd
- Product
- Mazor X. Model Number REF TPL0059; stereotaxic orthopedic instrument
- Status
- Open, Classified
- Initiated
- 2024-07-17
- Posted
- 2024-09-16
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Device Design
- Action
- Medtronic/Mazor Robotics, Ltd. issued an URGENT: Medical Device Software Correction to its consignees on 07/17/2024 via 2-day tracked mailing. The notice explained the issue, potential risk, and provided a workaround until the software update is installed. Medtronic will schedule a time to perform a software update that will resolve these anomalies. Medtronic field service engineers will update all Mazor X systems from version 5.1.1 to version 5.1.2 or later. Questions: contact Medtronic Technical Services at 1-888-826-5603 or rs.navtechsupport@medtronic.com .
- Quantity
- 94 devices
- Distribution
- US Nationwide distribution in PR.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K230064"]
- PMA numbers
- not on file
- Product code
- OLO
- Firm FEI
- 3005075696
- Firm city
- Caesarea
- Firm state
- not on file
- Firm country
- Israel
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28