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  "name": "3:1 Dermacarrier, Model Number 00219501300, skin graft carrier",
  "description": "FDA recall Z-1078-2024 — Zimmer Surgical Inc is recalling 3:1 Dermacarrier, Model Number 00219501300, skin graft carrier (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-1078-2024: Zimmer Surgical Inc is recalling 3:1 Dermacarrier, Model Number 00219501300, skin graft carrier",
      "text": "The FDA logged enforcement record Z-1078-2024: Zimmer Surgical Inc is voluntarily recalling 3:1 Dermacarrier, Model Number 00219501300, skin graft carrier — reason: Due to manufacturing issue, the product is labeled as 3:1 ratio, but the ridge pattern is a 1.5:1 ratio. The problem may lead to minor tissue damage or additional unplanned graft if deemed necessary.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-01-02. Affected lots/codes: UDI-DI 00889024378780 Lots 65292843 (Expires 16-Oct-2026) and 65390419 (Expires 18-Jan-2027). A RECORDED FDA enforcement action (occurred=true).",
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      "name": "FDA classified recall Z-1078-2024 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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