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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1133-2026.jsonld",
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  "name": "Brand Name: MicroPort  Product Name: HIPTURN FEM HEAD TRIAL 36MM REUSABLE  Model/Catalog Number: HTHT0036  Software Version: N/A  Product Description: HIPTURN FEM HEAD TRIAL 36MM REUSABLE",
  "description": "FDA recall Z-1133-2026 — MicroPort Orthopedics Inc. is recalling Brand Name: MicroPort  Product Name: HIPTURN FEM HEAD TRIAL 36MM REUSABLE  Model/Catalog Number: HTHT0036  Software Version: N/A  Product Description: HIPTURN FEM HEAD TRIAL 36MM REUSABLE (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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  "dateModified": "2026-06-24T07:02:03.626072+00:00",
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    "name": "Brand Name: MicroPort  Product Name: HIPTURN FEM HEAD TRIAL 36MM REUSABLE  Model/Catalog Number: HTHT0036  Software Version: N/A  Product Description: HIPTURN FEM HEAD TRIAL 36MM REUSABLE",
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      "name": "FDA recall Z-1133-2026: MicroPort Orthopedics Inc. is recalling Brand Name: MicroPort  Product Name: HIPTURN FEM HEAD TRIAL 36MM REUSABLE  Model/Catalog Number: HTHT0036  Software Version: N/A  Product Description: HIPTURN FEM HEAD TRIAL 36MM REUSABLE",
      "text": "The FDA logged enforcement record Z-1133-2026: MicroPort Orthopedics Inc. is voluntarily recalling Brand Name: MicroPort  Product Name: HIPTURN FEM HEAD TRIAL 36MM REUSABLE  Model/Catalog Number: HTHT0036  Software Version: N/A  Product Description: HIPTURN FEM HEAD TRIAL 36MM REUSABLE — reason: Due to products not having FDA Premarket authorization to be distributed within the United States.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-12-19. Affected lots/codes: Lot Code: Part Number HTHT0036, all lots, no future lots planned. Primary DI Number 00192629320130. Secondary Device ID M684HTHT00361. A RECORDED FDA enforcement action (occurred=true).",
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        "value": "Devices recall, status Ongoing",
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      "falsifier": "A RECORD of measured/reported events (occurred=true) from openFDA drug & device enforcement (recall) reports — U.S. FDA; superseded when openFDA drug & device enforcement (recall) reports — U.S. FDA publishes its next release."
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      "name": "FDA classified recall Z-1133-2026 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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      "falsifier": "occurred=FALSE: a regulatory DETERMINATION (an authority's classification/judgment) has NO material truthmaker independent of recognition — it is constituted by U.S. FDA recall classification (openFDA enforcement)'s say-so (a Searle institutional fact), not measured. adjudged=TRUE because U.S. FDA recall classification (openFDA enforcement) (an external authority) issued it. Distinct from a recorded measurement (which has an independent truthmaker) and from a modeled figure (a computed quantity, not a verdict). Challengeable; superseded if the authority reclassifies."
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      "@type": "schema:Claim",
      "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.",
      "claimType": "interpretation",
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      "epistemicStatus": {
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        "adjudicator": null
      },
      "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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            "Status": "recorded"
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            "Field": "Distribution pattern",
            "Value": "The product was sent to distributors in multiple US states, including Texas, California, Wisconsin, Kansas, Illinois, Michigan, Tennessee, Maryland, Washington, Georgia, Colorado, Missouri, and Florida.  The product was also sent to the following countries: Belgium, Germany, France, Italy, United Kingdom, Japan, and China.",
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