FDAJuly 17, 2024device
Mazor X. Model Number REF TPL0059; stereotaxic orthopedic instrument
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Ongoing
Brands named
mazor roboticsmazor
UPCs
0729010918046540038122016400440220174006706201740069062017072901091811580729010918409807290115751376
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAMazor X robotic guidance system REF: TPL00592025-12-10
- 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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