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  "name": "LINK SLED Knee System:  ENDO SLED KNEE FEM COMP, MEDIUM     Item Number: 15-2020/52",
  "description": "FDA recall Z-1509-2023 — Linkbio Corp. is recalling LINK SLED Knee System:  ENDO SLED KNEE FEM COMP, MEDIUM     Item Number: 15-2020/52 (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-1509-2023: Linkbio Corp. is recalling LINK SLED Knee System:  ENDO SLED KNEE FEM COMP, MEDIUM     Item Number: 15-2020/52",
      "text": "The FDA logged enforcement record Z-1509-2023: Linkbio Corp. is voluntarily recalling LINK SLED Knee System:  ENDO SLED KNEE FEM COMP, MEDIUM     Item Number: 15-2020/52 — reason: Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the implant or inadequate cementing technique leading to an unsatisfactory surgical result, and in the worst case, intervention or revision earlier than expected. Status: Ongoing — the recall is still being carried out.. Initiated 2023-03-21. Affected lots/codes: UDI-DI: 04026575043903  All lot numbers within the labeled expiration date. A RECORDED FDA enforcement action (occurred=true).",
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      "name": "FDA classified recall Z-1509-2023 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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            "Value": "Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the implant or inadequate cementing technique leading to an unsatisfactory surgical result, and in the worst case, intervention or revision earlier than expected",
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            "Value": "NY, NV Foreign:  Bulgaria, France, Italy, Norway, Poland, Sweden, Switzerland, Slovakia, Spain, United Kingdom, Germany, Austria, Argentina, Australia, China, India, Iraq, Jordan, Colombia, Mexico, Saudi Arabia, Ukraine, Vietnam, and Belarus",
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