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  "name": "IdentiTi ALIF Standalone Interbody System:  Part Number/Description  132-10-85-250 / IdentiTi ALIF SA Graft Bolt, 08.5 x 25 mm  132-10-85-300 / IdentiTi ALIF SA Graft Bolt, 08.5 x 30 mm  132-10-85-350 / IdentiTi ALIF SA Graft Bolt, 08.5 x 35 mm  132-10-90-250 / IdentiTi ALIF SA Graft Bolt, 09 x 25 mm  132-10-90-300 / IdentiTi ALIF SA Graft Bolt, 09 x 30 mm  132-10-90-350 / IdentiTi ALIF SA Graft Bolt, 09 x 35 mm  232-10-85-250 / IdentiTi ALIF SA Graft Bolt, 08.5 x 25 mm  232-10-85-300 / IdentiTi ALIF SA Graft Bolt, 08.5 x 30 mm  232-10-85-350 / IdentiTi ALIF SA Graft Bolt, 08.5 x 35 mm  232-11-90-250 / IdentiTi ALIF SA Cannulated Graft Bolt, 09 x 25 mm  232-11-90-300 / IdentiTi ALIF SA Cannulated Graft Bolt, 09 x 30 mm  232-11-90-350 / IdentiTi ALIF SA Cannulated Graft Bolt, 09 x 35 mm    The IdentiTi ALIF Standalone Interbody System is an integrated intervertebral body fusion device for use in anterior lumbar interbody fusion (ALIF) procedures.",
  "description": "FDA recall Z-1182-2024 — Alphatec Spine, Inc. is recalling IdentiTi ALIF Standalone Interbody System:  Part Number/Description  132-10-85-250 / IdentiTi ALIF SA Graft Bolt, 08.5 x 25 mm  132-10-85-300 / IdentiTi ALIF SA Graft Bolt, 08.5 x 30 mm  132-10-85-350 / IdentiTi ALIF SA Graft Bolt, 08.5 x 35 mm  132-10-90-250 / IdentiTi ALIF SA Graft Bolt, 09 x 25 mm  132-10-90-300 / IdentiTi ALIF SA Graft Bolt, 09 x 30 mm  132-10-90-350 / IdentiTi ALIF SA Graft Bolt, 09 x 35 mm  232-10-85-250 / IdentiTi ALIF SA Graft Bolt, 08.5 x 25 mm  232-10-85-300 / IdentiTi ALIF SA Graft Bolt, 08.5 x 30 mm  232-10-85-350 / IdentiTi ALIF SA Graft Bolt, 08.5 x 35 mm  232-11-90-250 / IdentiTi ALIF SA Cannulated Graft Bolt, 09 x 25 mm  232-11-90-300 / IdentiTi ALIF SA Cannulated Graft Bolt, 09 x 30 mm  232-11-90-350 / IdentiTi ALIF SA Cannulated Graft Bolt, 09 x 35 mm    The IdentiTi ALIF Standalone Interbody System is an integrated intervertebral body fusion device for use in anterior lumbar interbody fusion (ALIF) procedures. (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": "IdentiTi ALIF Standalone Interbody System:  Part Number/Description  132-10-85-250 / IdentiTi ALIF SA Graft Bolt, 08.5 x 25 mm  132-10-85-300 / IdentiTi ALIF SA Graft Bolt, 08.5 x 30 mm  132-10-85-350 / IdentiTi ALIF SA Graft Bolt, 08.5 x 35 mm  132-10-90-250 / IdentiTi ALIF SA Graft Bolt, 09 x 25 mm  132-10-90-300 / IdentiTi ALIF SA Graft Bolt, 09 x 30 mm  132-10-90-350 / IdentiTi ALIF SA Graft Bolt, 09 x 35 mm  232-10-85-250 / IdentiTi ALIF SA Graft Bolt, 08.5 x 25 mm  232-10-85-300 / IdentiTi ALIF SA Graft Bolt, 08.5 x 30 mm  232-10-85-350 / IdentiTi ALIF SA Graft Bolt, 08.5 x 35 mm  232-11-90-250 / IdentiTi ALIF SA Cannulated Graft Bolt, 09 x 25 mm  232-11-90-300 / IdentiTi ALIF SA Cannulated Graft Bolt, 09 x 30 mm  232-11-90-350 / IdentiTi ALIF SA Cannulated Graft Bolt, 09 x 35 mm    The IdentiTi ALIF Standalone Interbody System is an integrated intervertebral body fusion device for use in anterior lumbar interbody fusion (ALIF) procedures.",
    "manufacturer": {
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      "name": "Alphatec Spine, Inc."
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1182-2024/enforcement-record",
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      "name": "FDA recall Z-1182-2024: Alphatec Spine, Inc. is recalling IdentiTi ALIF Standalone Interbody System:  Part Number/Description  132-10-85-250 / IdentiTi ALIF SA Graft Bolt, 08.5 x 25 mm  132-10-85-300 / IdentiTi ALIF SA Graft Bolt, 08.5 x 30 mm  132-10-85-350 / IdentiTi ALIF SA Graft Bolt, 08.5 x 35 mm  132-10-90-250 / IdentiTi ALIF SA Graft Bolt, 09 x 25 mm  132-10-90-300 / IdentiTi ALIF SA Graft Bolt, 09 x 30 mm  132-10-90-350 / IdentiTi ALIF SA Graft Bolt, 09 x 35 mm  232-10-85-250 / IdentiTi ALIF SA Graft Bolt, 08.5 x 25 mm  232-10-85-300 / IdentiTi ALIF SA Graft Bolt, 08.5 x 30 mm  232-10-85-350 / IdentiTi ALIF SA Graft Bolt, 08.5 x 35 mm  232-11-90-250 / IdentiTi ALIF SA Cannulated Graft Bolt, 09 x 25 mm  232-11-90-300 / IdentiTi ALIF SA Cannulated Graft Bolt, 09 x 30 mm  232-11-90-350 / IdentiTi ALIF SA Cannulated Graft Bolt, 09 x 35 mm    The IdentiTi ALIF Standalone Interbody System is an integrated intervertebral body fusion device for use in anterior lumbar interbody fusion (ALIF) procedures.",
      "text": "The FDA logged enforcement record Z-1182-2024: Alphatec Spine, Inc. is voluntarily recalling IdentiTi ALIF Standalone Interbody System:  Part Number/Description  132-10-85-250 / IdentiTi ALIF SA Graft Bolt, 08.5 x 25 mm  132-10-85-300 / IdentiTi ALIF SA Graft Bolt, 08.5 x 30 mm  132-10-85-350 / IdentiTi ALIF SA Graft Bolt, 08.5 x 35 mm  132-10-90-250 / IdentiTi ALIF SA Graft Bolt, 09 x 25 mm  132-10-90-300 / IdentiTi ALIF SA Graft Bolt, 09 x 30 mm  132-10-90-350 / IdentiTi ALIF SA Graft Bolt, 09 x 35 mm  232-10-85-250 / IdentiTi ALIF SA Graft Bolt, 08.5 x 25 mm  232-10-85-300 / IdentiTi ALIF SA Graft Bolt, 08.5 x 30 mm  232-10-85-350 / IdentiTi ALIF SA Graft Bolt, 08.5 x 35 mm  232-11-90-250 / IdentiTi ALIF SA Cannulated Graft Bolt, 09 x 25 mm  232-11-90-300 / IdentiTi ALIF SA Cannulated Graft Bolt, 09 x 30 mm  232-11-90-350 / IdentiTi ALIF SA Cannulated Graft Bolt, 09 x 35 mm    The IdentiTi ALIF Standalone Interbody System is an integrated intervertebral body fusion device for use in anterior lumbar interbody fusion (ALIF) procedures. — reason: Due to reports of intraoperative graft bolt implantation breakages.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-01-26. Affected lots/codes: Part Number / Product Description / UDI-DI Code / Lot Number 132-10-85-250 / IdentiTi ALIF SA Graft Bolt, 08.5 x 25 mm UDI-DI code: 00190376299716 Lot Numbers: 8746709, 8746724, TO00212  132-10-85-300 / IdentiTi ALIF SA Graft Bolt, 08.5 x 30 mm UDI-DI code: 00190376299730 Lot Numbers: 8746710, 8746725, TO00213  132-10-85-350 / IdentiTi ALIF SA Graft Bolt, 08.5 x 35 mm UDI-DI code: 00190376299754 Lot Numbers: 8746711, TO00218  132-10-90-250 / IdentiTi ALIF SA Graft Bolt, 09 x 25 mm UDI-DI code: 00190376299792 Lot Numbers: 8746712  132-10-90-300 / IdentiTi ALIF SA Graft Bolt, 09 x 30 mm UDI-DI code: 00190376299815 Lot Numbers: 6746713  132-10-90-350 / IdentiTi ALIF SA Graft Bolt, 09 x 35 mm UDI-DI code: 00190376299839 Lot Numbers: 8746714  232-10-85-250 / IdentiTi ALIF SA Graft Bolt, 08.5 x 25 mm UDI-DI code: 00190376369976 Lot Numbers: TO00373, TO00670, TO00694, TO00834, TO01038, TO01404, TO01514, TO01572, TO01573, TO01696, TO01974, TO01979, TO01982, TO02297, TO02393, TO03218, TO03465  232-10-85-300 / IdentiTi ALIF SA Graft Bolt, 08.5 x 30 mm UDI-DI code: 00190376369990 Lot Numbers: TO00376, TO00671, TO00695, TO00710, TO00835, TO01039, TO01405, TO01515, TO01574, TO01575, TO01697, TO01975, TO01980, TO01983, TO02298, TO02394, TO03219, TO03466  232-10-85-350 / IdentiTi ALIF SA Graft Bolt, 08.5 x 35 mm UDI-DI code: 00190376370019 Lot Numbers: TO00380, TO00672, TO00696, TO00836, TO01576, TO01577, TO02163, TO02395  232-11-90-250 / IdentiTi ALIF SA Cannulated Graft Bolt, 09 x 25 mm UDI-DI code: 00190376370293 Lot Numbers: TO00381, TO00673, TO00697, TO01277, TO01578, TO02396  232-11-90-300 / IdentiTi ALIF SA Cannulated Graft Bolt, 09 x 30 mm UDI-DI code: 00190376370316 Lot Numbers: TO00382, TO00674, TO00698, TO01040, TO01406, TO02164, TO02397, TO03220  232-11-90-350 / IdentiTi ALIF SA Cannulated Graft Bolt, 09 x 35 mm UDI-DI code: 00190376370330 Lot Numbers: TO00383, TO00699, TO01407, TO02398. 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-1182-2024 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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        "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-1182-2024/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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        "source": "Atlas Commons L5 boundary (enforcement-action ≠ harm causation)",
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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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            "Value": "Devices",
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            "Value": "Ongoing — the recall is still being carried out.",
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            "Field": "Recalling firm",
            "Value": "Alphatec Spine, Inc.",
            "Status": "recorded"
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          "item": {
            "Field": "Reason",
            "Value": "Due to reports of intraoperative graft bolt implantation breakages.",
            "Status": "recorded"
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          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2024-01-26",
            "Status": "recorded"
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          "item": {
            "Field": "Lot/code info",
            "Value": "Part Number / Product Description / UDI-DI Code / Lot Number 132-10-85-250 / IdentiTi ALIF SA Graft Bolt, 08.5 x 25 mm UDI-DI code: 00190376299716 Lot Numbers: 8746709, 8746724, TO00212  132-10-85-300 / IdentiTi ALIF SA Graft Bolt, 08.5 x 30 mm UDI-DI code: 00190376299730 Lot Numbers: 8746710, 8746725, TO00213  132-10-85-350 / IdentiTi ALIF SA Graft Bolt, 08.5 x 35 mm UDI-DI code: 00190376299754 Lot Numbers: 8746711, TO00218  132-10-90-250 / IdentiTi ALIF SA Graft Bolt, 09 x 25 mm UDI-DI code: 00190376299792 Lot Numbers: 8746712  132-10-90-300 / IdentiTi ALIF SA Graft Bolt, 09 x 30 mm UDI-DI code: 00190376299815 Lot Numbers: 6746713  132-10-90-350 / IdentiTi ALIF SA Graft Bolt, 09 x 35 mm UDI-DI code: 00190376299839 Lot Numbers: 8746714  232-10-85-250 / IdentiTi ALIF SA Graft Bolt, 08.5 x 25 mm UDI-DI code: 00190376369976 Lot Numbers: TO00373, TO00670, TO00694, TO00834, TO01038, TO01404, TO01514, TO01572, TO01573, TO01696, TO01974, TO01979, TO01982, TO02297, TO02393, TO03218, TO03465  232-10-85-300 / IdentiTi ALIF SA Graft Bolt, 08.5 x 30 mm UDI-DI code: 00190376369990 Lot Numbers: TO00376, TO00671, TO00695, TO00710, TO00835, TO01039, TO01405, TO01515, TO01574, TO01575, TO01697, TO01975, TO01980, TO01983, TO02298, TO02394, TO03219, TO03466  232-10-85-350 / IdentiTi ALIF SA Graft Bolt, 08.5 x 35 mm UDI-DI code: 00190376370019 Lot Numbers: TO00380, TO00672, TO00696, TO00836, TO01576, TO01577, TO02163, TO02395  232-11-90-250 / IdentiTi ALIF SA Cannulated Graft Bolt, 09 x 25 mm UDI-DI code: 00190376370293 Lot Numbers: TO00381, TO00673, TO00697, TO01277, TO01578, TO02396  232-11-90-300 / IdentiTi ALIF SA Cannulated Graft Bolt, 09 x 30 mm UDI-DI code: 00190376370316 Lot Numbers: TO00382, TO00674, TO00698, TO01040, TO01406, TO02164, TO02397, TO03220  232-11-90-350 / IdentiTi ALIF SA Cannulated Graft Bolt, 09 x 35 mm UDI-DI code: 00190376370330 Lot Numbers: TO00383, TO00699, TO01407, TO02398",
            "Status": "recorded"
          }
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          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide - U.S. Nationwide distribution including in the states of AL, AZ, CA, CO, CT, FL, GA, IA, ID, IN, KS, KY, MD, MI, MN, MS, NC, NH, NV, NY, OH, OK, OR, PA, Puerto Rico, SC, SD, TN, TX, UT, WA and WI. The country of New Zealand.",
            "Status": "recorded"
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