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  "name": "TxHA PEEK IBF/TxTiHA IBF System REF BTA-151    i. TxHA   The Innovasis TxHA PEEK IBF System is an intervertebral body fusion device intended to stabilize a spinal segment to promote fusion using bone graft, in order to restrict motion and decrease pain. Users of these products are limited to physicians trained in orthopedic surgery. Clinical locations include hospitals and surgery sites equipped to perform spinal surgery.  ii. TxTiHA   The Innovasis TxTiHA IBF System is an intervertebral body fusion device intended to stabilize a spinal segment to promote fusion using bone graft, in order to restrict motion and decrease pain.",
  "description": "FDA recall Z-3163-2024 — Innovasis, Inc is recalling TxHA PEEK IBF/TxTiHA IBF System REF BTA-151    i. TxHA   The Innovasis TxHA PEEK IBF System is an intervertebral body fusion device intended to stabilize a spinal segment to promote fusion using bone graft, in order to restrict motion and decrease pain. Users of these products are limited to physicians trained in orthopedic surgery. Clinical locations include hospitals and surgery sites equipped to perform spinal surgery.  ii. TxTiHA   The Innovasis TxTiHA IBF System is an intervertebral body fusion device intended to stabilize a spinal segment to promote fusion using bone graft, in order to restrict motion and decrease pain. (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": "TxHA PEEK IBF/TxTiHA IBF System REF BTA-151    i. TxHA   The Innovasis TxHA PEEK IBF System is an intervertebral body fusion device intended to stabilize a spinal segment to promote fusion using bone graft, in order to restrict motion and decrease pain. Users of these products are limited to physicians trained in orthopedic surgery. Clinical locations include hospitals and surgery sites equipped to perform spinal surgery.  ii. TxTiHA   The Innovasis TxTiHA IBF System is an intervertebral body fusion device intended to stabilize a spinal segment to promote fusion using bone graft, in order to restrict motion and decrease pain.",
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      "name": "Innovasis, Inc"
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-3163-2024/enforcement-record",
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      "name": "FDA recall Z-3163-2024: Innovasis, Inc is recalling TxHA PEEK IBF/TxTiHA IBF System REF BTA-151    i. TxHA   The Innovasis TxHA PEEK IBF System is an intervertebral body fusion device intended to stabilize a spinal segment to promote fusion using bone graft, in order to restrict motion and decrease pain. Users of these products are limited to physicians trained in orthopedic surgery. Clinical locations include hospitals and surgery sites equipped to perform spinal surgery.  ii. TxTiHA   The Innovasis TxTiHA IBF System is an intervertebral body fusion device intended to stabilize a spinal segment to promote fusion using bone graft, in order to restrict motion and decrease pain.",
      "text": "The FDA logged enforcement record Z-3163-2024: Innovasis, Inc is voluntarily recalling TxHA PEEK IBF/TxTiHA IBF System REF BTA-151    i. TxHA   The Innovasis TxHA PEEK IBF System is an intervertebral body fusion device intended to stabilize a spinal segment to promote fusion using bone graft, in order to restrict motion and decrease pain. Users of these products are limited to physicians trained in orthopedic surgery. Clinical locations include hospitals and surgery sites equipped to perform spinal surgery.  ii. TxTiHA   The Innovasis TxTiHA IBF System is an intervertebral body fusion device intended to stabilize a spinal segment to promote fusion using bone graft, in order to restrict motion and decrease pain. — reason: Due to interfacing issues between the implant trial and inserter of the lumbar intervertebral fusion device.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-08-14. Affected lots/codes: Part Number and Description: LS-397-0705  Implant Trial, 10 x 7 x 28mm x 5¿, Tx UDI-DI code: M711LS39707050 Serial Numbers: 001-012 013-025  Part Number and Description: LS-397-0805 Implant Trial, 10 x 8 x 28mm x 5¿, Tx UDI-DI Code: M711LS39708050 Serial Numbers: 001-012 013-026  Part Number and Description: LS-397-0905  Implant Trial, 10 x 9 x 28mm x 5¿, Tx UDI-DI code: M711LS39709050 Serial Numbers: 001-012 013-027  Part Number and Description: LS-397-1005  Implant Trial, 10 x 10 x 28mm x 5¿, Tx UDI-Di code: M711LS39710050 Serial Numbers: 001-012 013-027  Part Number and Description: LS-397-1105  Implant Trial, 10 x 11 x 28mm x 5¿, Tx UDI-DI code: M711LS39711050 Serial Numbers: 001-012 013-027  Part Number and Description: LS-397-0810  Implant Trial, 10 x 08 x 28mm x 10¿, Tx UDI_DI code: M711LS39708100 Serial Numbers: 001-012 013-026  Part Number and Description: LS-397-0910  Implant Trial, 10 x 09 x 28mm x 10¿, Tx UDI-DI code: M711LS39709100 Serial Numbers: 001-012 013-026  Part Number and Description: LS-397-1010  Implant Trial, 10 x 10 x 28mm x 10¿, Tx UDI-DI code: M711LS39710100 Serial Numbers: 001-012 013-026  Part Number and Description: LS-397-1110  Implant Trial, 10 x 11 x 28mm x 10¿, Tx +M711LS39711100E 001-012 013-026  Part Number and Description: LS-397-0912  Implant Trial, 10 x 09 x 28mm x 12.5¿, Tx UDI-DI code: M711LS39709120 Serial Numbers: 001-012 013-024  Part Number and Description: LS-397-1012  Implant Trial, 10 x 10 x 28mm x 12.5¿, Tx UDI-DI code: M711LS39710120 Serial Numbers: 001-012 013-024  Part Number and Description: LS-397-1112  Implant Trial, 10 x 11 x 28mm x 12.5¿, Tx UDI_DI code: M711LS39711120 Serial Numbers: 001-012 013-025  Part Number and Description: LS-433-0805  Implant Trial, 12 x 8 x 32mm x 5¿, Tx UDI-DI code: M711LS43308050 Serial Numbers: 001-012 013-026  Part Number and Description: LS-433-0905  Implant Trial, 12 x 9 x 32mm x 5¿, Tx UDI-DI code: M711LS43309050 Serial Numbers: 001-012 013-027  Part Number and Description: LS-433-1005  Implant Trial, 12 x 10 x 32mm x 5¿, Tx UDI-DI code: M711LS43310050 Serial Numbers: 001-012 013-027  Part Number and Description: LS-433-1105  Implant Trial, 12 x 11 x 32mm x 5¿, Tx UDI-DI code: M711LS43311050 Serial Numbers: 001-012 013-026  Part Number and Description: LS-433-0910  Implant Trial, 12 x 09 x 32mm x 10¿, Tx UDI-DI code: M711LS43309100 Serial Numbers: 001-012 013-026  Part Number and Description: LS-433-1010  Implant Trial, 12 x 10 x 32mm x 10¿, Tx UDI-DI code: M711LS43310100 Serial Numbers: 001-012 013-028  Part Number and Description: LS-433-1110  Implant Trial, 12 x 11 x 32mm x 10¿, Tx UDI-DI code: M711LS43311100 Serial Numbers: 001-012 013-026  Part Number and Description: LS-433-0912  Implant Trial, 12 x 09 x 32mm x 12.5¿, Tx UDI-DI code: M711LS43309120 Serial Numbers: 001-012 013-024  Part Number and Description: LS-433-1012  Implant Trial, 12 x 10 x 32mm x 12.5¿, Tx UDI-DI code: M711LS43310120 Serial Numbers: 001-012 013-025  Part Number and Description: LS-433-1112  Implant Trial, 12 x 11 x 32mm x 12.5¿, Tx UDI-DI code: M711LS43311120 Serial Numbers: 001-012 013-024. A RECORDED FDA enforcement action (occurred=true).",
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        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-3163-2024&lang=eng",
        "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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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-3163-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-3163-2024 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.",
      "claimType": "regulatory_determination",
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      "epistemicStatus": {
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        "source": "U.S. FDA recall classification (openFDA enforcement)",
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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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      "@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
      },
      "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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            "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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          "item": {
            "Field": "Recalling firm",
            "Value": "Innovasis, Inc",
            "Status": "recorded"
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Due to interfacing issues between the implant trial and inserter of the lumbar intervertebral fusion device.",
            "Status": "recorded"
          }
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          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2024-08-14",
            "Status": "recorded"
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          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "Part Number and Description: LS-397-0705  Implant Trial, 10 x 7 x 28mm x 5¿, Tx UDI-DI code: M711LS39707050 Serial Numbers: 001-012 013-025  Part Number and Description: LS-397-0805 Implant Trial, 10 x 8 x 28mm x 5¿, Tx UDI-DI Code: M711LS39708050 Serial Numbers: 001-012 013-026  Part Number and Description: LS-397-0905  Implant Trial, 10 x 9 x 28mm x 5¿, Tx UDI-DI code: M711LS39709050 Serial Numbers: 001-012 013-027  Part Number and Description: LS-397-1005  Implant Trial, 10 x 10 x 28mm x 5¿, Tx UDI-Di code: M711LS39710050 Serial Numbers: 001-012 013-027  Part Number and Description: LS-397-1105  Implant Trial, 10 x 11 x 28mm x 5¿, Tx UDI-DI code: M711LS39711050 Serial Numbers: 001-012 013-027  Part Number and Description: LS-397-0810  Implant Trial, 10 x 08 x 28mm x 10¿, Tx UDI_DI code: M711LS39708100 Serial Numbers: 001-012 013-026  Part Number and Description: LS-397-0910  Implant Trial, 10 x 09 x 28mm x 10¿, Tx UDI-DI code: M711LS39709100 Serial Numbers: 001-012 013-026  Part Number and Description: LS-397-1010  Implant Trial, 10 x 10 x 28mm x 10¿, Tx UDI-DI code: M711LS39710100 Serial Numbers: 001-012 013-026  Part Number and Description: LS-397-1110  Implant Trial, 10 x 11 x 28mm x 10¿, Tx +M711LS39711100E 001-012 013-026  Part Number and Description: LS-397-0912  Implant Trial, 10 x 09 x 28mm x 12.5¿, Tx UDI-DI code: M711LS39709120 Serial Numbers: 001-012 013-024  Part Number and Description: LS-397-1012  Implant Trial, 10 x 10 x 28mm x 12.5¿, Tx UDI-DI code: M711LS39710120 Serial Numbers: 001-012 013-024  Part Number and Description: LS-397-1112  Implant Trial, 10 x 11 x 28mm x 12.5¿, Tx UDI_DI code: M711LS39711120 Serial Numbers: 001-012 013-025  Part Number and Description: LS-433-0805  Implant Trial, 12 x 8 x 32mm x 5¿, Tx UDI-DI code: M711LS43308050 Serial Numbers: 001-012 013-026  Part Number and Description: LS-433-0905  Implant Trial, 12 x 9 x 32mm x 5¿, Tx UDI-DI code: M711LS43309050 Serial Numbers: 001-012 013-027  Part Number and Description: LS-433-1005  Implant Trial, 12 x 10 x 32mm x 5¿, Tx UDI-DI code: M711LS43310050 Serial Numbers: 001-012 013-027  Part Number and Description: LS-433-1105  Implant Trial, 12 x 11 x 32mm x 5¿, Tx UDI-DI code: M711LS43311050 Serial Numbers: 001-012 013-026  Part Number and Description: LS-433-0910  Implant Trial, 12 x 09 x 32mm x 10¿, Tx UDI-DI code: M711LS43309100 Serial Numbers: 001-012 013-026  Part Number and Description: LS-433-1010  Implant Trial, 12 x 10 x 32mm x 10¿, Tx UDI-DI code: M711LS43310100 Serial Numbers: 001-012 013-028  Part Number and Description: LS-433-1110  Implant Trial, 12 x 11 x 32mm x 10¿, Tx UDI-DI code: M711LS43311100 Serial Numbers: 001-012 013-026  Part Number and Description: LS-433-0912  Implant Trial, 12 x 09 x 32mm x 12.5¿, Tx UDI-DI code: M711LS43309120 Serial Numbers: 001-012 013-024  Part Number and Description: LS-433-1012  Implant Trial, 12 x 10 x 32mm x 12.5¿, Tx UDI-DI code: M711LS43310120 Serial Numbers: 001-012 013-025  Part Number and Description: LS-433-1112  Implant Trial, 12 x 11 x 32mm x 12.5¿, Tx UDI-DI code: M711LS43311120 Serial Numbers: 001-012 013-024",
            "Status": "recorded"
          }
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          "item": {
            "Field": "Distribution pattern",
            "Value": "U.S. Nationwide distribution in the states of AL, CA, CO, FL, ID, MI, SD, TX and WI.",
            "Status": "recorded"
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