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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2222-2025.jsonld",
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  "name": "Brand Name: Osteotec  Product Name: Osteotec Silicone Finger Implant  Model/Catalog Number: OSTF-3 (Sz. 3), OSTF-4 (Sz. 4), OSTF-5 (Sz. 5)  Software Version: N/A  Product Description: The Osteotec Silicone Finger Implant is a one-piece, sterile, flexible silicone elastomer implant which  is placed, during arthroplasty, in the proximal and distal intramedullary canals of either  metacarpophalangeal (MCP) or proximal interphalangeal (PIP) joints. The implant is not fixed into the  bones and becomes stabilized by the encapsulation process. The implant is available in eleven sizes  to meet various anatomical variations and is supplied sterile.  Component: N/A",
  "description": "FDA recall Z-2222-2025 — Osteotec Limited is recalling Brand Name: Osteotec  Product Name: Osteotec Silicone Finger Implant  Model/Catalog Number: OSTF-3 (Sz. 3), OSTF-4 (Sz. 4), OSTF-5 (Sz. 5)  Software Version: N/A  Product Description: The Osteotec Silicone Finger Implant is a one-piece, sterile, flexible silicone elastomer implant which  is placed, during arthroplasty, in the proximal and distal intramedullary canals of either  metacarpophalangeal (MCP) or proximal interphalangeal (PIP) joints. The implant is not fixed into the  bones and becomes stabilized by the encapsulation process. The implant is available in eleven sizes  to meet various anatomical variations and is supplied sterile.  Component: N/A (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": "openFDA drug & device enforcement (recall) reports",
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    "@type": "schema:MedicalDevice",
    "name": "Brand Name: Osteotec  Product Name: Osteotec Silicone Finger Implant  Model/Catalog Number: OSTF-3 (Sz. 3), OSTF-4 (Sz. 4), OSTF-5 (Sz. 5)  Software Version: N/A  Product Description: The Osteotec Silicone Finger Implant is a one-piece, sterile, flexible silicone elastomer implant which  is placed, during arthroplasty, in the proximal and distal intramedullary canals of either  metacarpophalangeal (MCP) or proximal interphalangeal (PIP) joints. The implant is not fixed into the  bones and becomes stabilized by the encapsulation process. The implant is available in eleven sizes  to meet various anatomical variations and is supplied sterile.  Component: N/A",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Osteotec Limited"
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2222-2025/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2222-2025: Osteotec Limited is recalling Brand Name: Osteotec  Product Name: Osteotec Silicone Finger Implant  Model/Catalog Number: OSTF-3 (Sz. 3), OSTF-4 (Sz. 4), OSTF-5 (Sz. 5)  Software Version: N/A  Product Description: The Osteotec Silicone Finger Implant is a one-piece, sterile, flexible silicone elastomer implant which  is placed, during arthroplasty, in the proximal and distal intramedullary canals of either  metacarpophalangeal (MCP) or proximal interphalangeal (PIP) joints. The implant is not fixed into the  bones and becomes stabilized by the encapsulation process. The implant is available in eleven sizes  to meet various anatomical variations and is supplied sterile.  Component: N/A",
      "text": "The FDA logged enforcement record Z-2222-2025: Osteotec Limited is voluntarily recalling Brand Name: Osteotec  Product Name: Osteotec Silicone Finger Implant  Model/Catalog Number: OSTF-3 (Sz. 3), OSTF-4 (Sz. 4), OSTF-5 (Sz. 5)  Software Version: N/A  Product Description: The Osteotec Silicone Finger Implant is a one-piece, sterile, flexible silicone elastomer implant which  is placed, during arthroplasty, in the proximal and distal intramedullary canals of either  metacarpophalangeal (MCP) or proximal interphalangeal (PIP) joints. The implant is not fixed into the  bones and becomes stabilized by the encapsulation process. The implant is available in eleven sizes  to meet various anatomical variations and is supplied sterile.  Component: N/A — reason: There is the potential that the silicone implant may contain foreign material. Status: Ongoing — the recall is still being carried out.. Initiated 2025-06-18. Affected lots/codes: Lot Code: OSTF-3 LOT 127707 Exp 07/17/2028, UDI-DI:5060183090040 OSTF-4 LOT 127708 Exp 07/17/2028, UDI-DI:5060183090057 OSTF-5 LOT 127709 Exp 07/17/2028, UDI-DI:5060183090064. A RECORDED FDA enforcement action (occurred=true).",
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        "value": "Devices recall, status Ongoing",
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      "name": "FDA classified recall Z-2222-2025 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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        "value": "Class II",
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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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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2222-2025/boundary",
      "@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.",
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        "value": "a recorded enforcement action, not proof of harm or causation; not medical advice",
        "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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      "name": "FDA recall details — Z-2222-2025",
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            "Value": "Z-2222-2025",
            "Status": "recorded"
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            "Value": "Devices",
            "Status": "recorded"
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            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
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            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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            "Field": "Recalling firm",
            "Value": "Osteotec Limited",
            "Status": "recorded"
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            "Field": "Reason",
            "Value": "There is the potential that the silicone implant may contain foreign material",
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            "Field": "Initiated",
            "Value": "2025-06-18",
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            "Status": "recorded"
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          "item": {
            "Field": "Distribution pattern",
            "Value": "US Nationwide distribution in the state of CA.",
            "Status": "recorded"
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