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  "name": "EMPOWR 3D Knee Tibial Insert, 5R, 10MM, VE, REF: 342-10-705",
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      "name": "FDA recall Z-0102-2024: Encore Medical, LP is recalling EMPOWR 3D Knee Tibial Insert, 5R, 10MM, VE, REF: 342-10-705",
      "text": "The FDA logged enforcement record Z-0102-2024: Encore Medical, LP is voluntarily recalling EMPOWR 3D Knee Tibial Insert, 5R, 10MM, VE, REF: 342-10-705 — reason: Knee insert and acetabular system parts were swapped within inner pack prior to the product being sealed within the tray, which could result in surgeons not having the correct product for the surgery due to different anatomies (Hip vs Knee).. Status: Ongoing — the recall is still being carried out.. Initiated 2023-08-22. Affected lots/codes: UDI-DI: 00888912167321, Lot: 075T1167, Expiration: March 30, 2028. A RECORDED FDA enforcement action (occurred=true).",
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      "name": "FDA classified recall Z-0102-2024 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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      "name": "What an FDA recall is — and is NOT",
      "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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      "falsifier": "occurred=FALSE (a framing, not an event) and adjudged=FALSE (an in-house reading, not an authority's verdict) — the LOWEST-warrant claim here. A flat representation would render this identically to the official facts; the four-status does not."
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