FDADecember 10, 2025device
Mazor X robotic guidance system REF: TPL0059
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Software errors that can result in incorrect surgical instrument positioning during spinal surgery.
What to do
FDA enforcement status: Ongoing
Brands named
mazor roboticsmazor
UPCs
072901091804650729010918452407290109181158007630006351690729010918321307290109184517007630004191340076300043176107290109184098072901091848380729011575137607290115751895
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAMazor X. Model Number REF TPL0059; stereotaxic orthopedic instrument2024-07-17
- FDAMAZOR X robotic guidance system, Model TPL0059, with software versions 4.2.2 or 5.0.12023-09-05
- FDATrexo Device2023-05-31
- CPSCModular Robotics Recalls Rechargeable Battery Packs Due to Burn Hazard2020-04-30
- FDASnapshot Tracker Kit, Mas2659-01, KIT0898, Rx Only, Non Sterile, UDI: 072901091818682019-07-02
- FDAi.v. Station and i.v. Station ONCO Automated Drug Compounding System, Pharmacy Compounding System Device Listing Number E4544482016-11-23
- FDACarousel MAS1025-01, part of the Brain Surgical Accessories Intra-operative Kit (KIT0295), accessory used with the Renaissance System (TPL0038). Indicated for precise positioning of surgical instruments or spinal implants during general spinal and brain surgery. It is intended to be used whenever...2014-11-26
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