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  "name": "Mazor X robotic guidance system  REF: TPL0059",
  "description": "FDA recall Z-1122-2026 — Mazor Robotics Ltd is recalling Mazor X robotic guidance system  REF: TPL0059 (Devices, Class II). The enforcement record is RECORDED; the classification is a DETERMINATION (FDA's regulatory verdict); the boundary is INTERPRETATION (a recall ≠ harm to a specific person). Source: openFDA. CC0.",
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      "name": "FDA recall Z-1122-2026: Mazor Robotics Ltd is recalling Mazor X robotic guidance system  REF: TPL0059",
      "text": "The FDA logged enforcement record Z-1122-2026: Mazor Robotics Ltd is voluntarily recalling Mazor X robotic guidance system  REF: TPL0059 — reason: Software errors that can result in incorrect surgical instrument positioning during spinal surgery.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-12-10. Affected lots/codes: Software versions: 5.0.1, 5.1.2, 5.1.3/ UDI: 07290109180465, 07290109184524, 07290109181158, 00763000635169, 07290109183213, 07290109184517, 00763000419134, 00763000431761, 07290109184098, 07290109184838, 07290115751376, 07290115751895. A RECORDED FDA enforcement action (occurred=true).",
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      "name": "FDA classified recall Z-1122-2026 as Class II",
      "text": "The FDA assigned this recall Class II: Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.. This is the FDA's official risk classification — its regulatory DETERMINATION of the hazard category (a verdict constituted by the FDA's recognition, occurred=FALSE), adjudged=TRUE because the FDA issued it. It is NOT a measurement of harm to any specific person.",
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      "text": "A recall is a RECORDED FDA enforcement action — the FDA logged that a firm is removing or correcting a product, classed by the FDA's risk judgment. It does NOT establish that any specific unit is affected or caused harm; causation is not established. This record informs and compares — it is NOT medical advice and does not tell anyone to start or stop a drug or device. For a medical decision, route to the FDA recall record and a licensed pharmacist or prescriber.",
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