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  "name": "Glidewell HT Implant Twist Drill ¿1.5 x 8 mm \"\tSKU # 70-1071-SRG0266  UDI code: +D7457071SRG02660/$$76254798/16D20250219V    The Glidewell HT\" Implant Twist Drill is indicated to prepare the site for placement of endosseous dental implants when tissue contact will last less than 1 hour.    The Glidewell HT\" Implant Twist Drill is used to remove bone from osteotomy during dental implant placement.  The initial Twist Drill is used to deepen the osteotomy and establish the trajectory of subsequent drills in the placement of a dental implant. The large Twist Drill is stepped to accmmodate the tapered design of the implant and is available in lengths corresponding to the availble implant lengths. Drill length is calculated to indicate where the top of the implant will reside when fully seated to that depth. The Twist Drill is machined from stainless steel.",
  "description": "FDA recall Z-1856-2025 — Prismatik Dentalcraft, Inc. is recalling Glidewell HT Implant Twist Drill ¿1.5 x 8 mm \"\tSKU # 70-1071-SRG0266  UDI code: +D7457071SRG02660/$$76254798/16D20250219V    The Glidewell HT\" Implant Twist Drill is indicated to prepare the site for placement of endosseous dental implants when tissue contact will last less than 1 hour.    The Glidewell HT\" Implant Twist Drill is used to remove bone from osteotomy during dental implant placement.  The initial Twist Drill is used to deepen the osteotomy and establish the trajectory of subsequent drills in the placement of a dental implant. The large Twist Drill is stepped to accmmodate the tapered design of the implant and is available in lengths corresponding to the availble implant lengths. Drill length is calculated to indicate where the top of the implant will reside when fully seated to that depth. The Twist Drill is machined from stainless steel. (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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    "@type": "schema:MedicalDevice",
    "name": "Glidewell HT Implant Twist Drill ¿1.5 x 8 mm \"\tSKU # 70-1071-SRG0266  UDI code: +D7457071SRG02660/$$76254798/16D20250219V    The Glidewell HT\" Implant Twist Drill is indicated to prepare the site for placement of endosseous dental implants when tissue contact will last less than 1 hour.    The Glidewell HT\" Implant Twist Drill is used to remove bone from osteotomy during dental implant placement.  The initial Twist Drill is used to deepen the osteotomy and establish the trajectory of subsequent drills in the placement of a dental implant. The large Twist Drill is stepped to accmmodate the tapered design of the implant and is available in lengths corresponding to the availble implant lengths. Drill length is calculated to indicate where the top of the implant will reside when fully seated to that depth. The Twist Drill is machined from stainless steel.",
    "manufacturer": {
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      "name": "Prismatik Dentalcraft, Inc."
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1856-2025/enforcement-record",
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      "name": "FDA recall Z-1856-2025: Prismatik Dentalcraft, Inc. is recalling Glidewell HT Implant Twist Drill ¿1.5 x 8 mm \"\tSKU # 70-1071-SRG0266  UDI code: +D7457071SRG02660/$$76254798/16D20250219V    The Glidewell HT\" Implant Twist Drill is indicated to prepare the site for placement of endosseous dental implants when tissue contact will last less than 1 hour.    The Glidewell HT\" Implant Twist Drill is used to remove bone from osteotomy during dental implant placement.  The initial Twist Drill is used to deepen the osteotomy and establish the trajectory of subsequent drills in the placement of a dental implant. The large Twist Drill is stepped to accmmodate the tapered design of the implant and is available in lengths corresponding to the availble implant lengths. Drill length is calculated to indicate where the top of the implant will reside when fully seated to that depth. The Twist Drill is machined from stainless steel.",
      "text": "The FDA logged enforcement record Z-1856-2025: Prismatik Dentalcraft, Inc. is voluntarily recalling Glidewell HT Implant Twist Drill ¿1.5 x 8 mm \"\tSKU # 70-1071-SRG0266  UDI code: +D7457071SRG02660/$$76254798/16D20250219V    The Glidewell HT\" Implant Twist Drill is indicated to prepare the site for placement of endosseous dental implants when tissue contact will last less than 1 hour.    The Glidewell HT\" Implant Twist Drill is used to remove bone from osteotomy during dental implant placement.  The initial Twist Drill is used to deepen the osteotomy and establish the trajectory of subsequent drills in the placement of a dental implant. The large Twist Drill is stepped to accmmodate the tapered design of the implant and is available in lengths corresponding to the availble implant lengths. Drill length is calculated to indicate where the top of the implant will reside when fully seated to that depth. The Twist Drill is machined from stainless steel. — reason: Due to packaging mix up.  Package of finished devices were reported to have an incorrect finished device package inside.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-04-14. Affected lots/codes: Glidewell HT Implant Twist Drill ¿1.5 x 8 mm SKU # 70-1071-SRG0266 UDI code: +D7457071SRG02660/$$76254798/16D20250219V Lot Number: 6254798. 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-1856-2025 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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      "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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      "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
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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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            "Field": "Reason",
            "Value": "Due to packaging mix up.  Package of finished devices were reported to have an incorrect finished device package inside.",
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            "Field": "Initiated",
            "Value": "2025-04-14",
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            "Value": "Glidewell HT Implant Twist Drill ¿1.5 x 8 mm SKU # 70-1071-SRG0266 UDI code: +D7457071SRG02660/$$76254798/16D20250219V Lot Number: 6254798",
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          "item": {
            "Field": "Distribution pattern",
            "Value": "U.S Nationwide distribution in the states of KY, MA, MI, NC, VA, and WV.",
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