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  "name": "Brand Name: ALTIVATE REVERSE  Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm  Model/Catalog Number: 506-04-122  Software Version: NA  Product Description: Encore Medical L.P. shoulder devices are intended for treatment of patients who are candidates for shoulder arthroplasty per the Indication for use. While total shoulder replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients.  Component: NA",
  "description": "FDA recall Z-2009-2025 — Encore Medical, LP is recalling Brand Name: ALTIVATE REVERSE  Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm  Model/Catalog Number: 506-04-122  Software Version: NA  Product Description: Encore Medical L.P. shoulder devices are intended for treatment of patients who are candidates for shoulder arthroplasty per the Indication for use. While total shoulder replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients.  Component: NA (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: ALTIVATE REVERSE  Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm  Model/Catalog Number: 506-04-122  Software Version: NA  Product Description: Encore Medical L.P. shoulder devices are intended for treatment of patients who are candidates for shoulder arthroplasty per the Indication for use. While total shoulder replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients.  Component: NA",
    "manufacturer": {
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      "name": "Encore Medical, LP"
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2009-2025/enforcement-record",
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      "name": "FDA recall Z-2009-2025: Encore Medical, LP is recalling Brand Name: ALTIVATE REVERSE  Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm  Model/Catalog Number: 506-04-122  Software Version: NA  Product Description: Encore Medical L.P. shoulder devices are intended for treatment of patients who are candidates for shoulder arthroplasty per the Indication for use. While total shoulder replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients.  Component: NA",
      "text": "The FDA logged enforcement record Z-2009-2025: Encore Medical, LP is voluntarily recalling Brand Name: ALTIVATE REVERSE  Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm  Model/Catalog Number: 506-04-122  Software Version: NA  Product Description: Encore Medical L.P. shoulder devices are intended for treatment of patients who are candidates for shoulder arthroplasty per the Indication for use. While total shoulder replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients.  Component: NA — reason: Package labeling for Altivate Reverse Torx Peripheral screw contains a different size  then actual  included product.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-05-28. Affected lots/codes: Lot Code: Item: 506-04-122 GTIN: 00190446829843 Lot: 5035A1018. A RECORDED FDA enforcement action (occurred=true).",
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        "value": "Devices recall, status Ongoing",
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          "name": "openFDA drug & device enforcement (recall) reports — U.S. FDA",
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      "name": "FDA classified recall Z-2009-2025 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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      "@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
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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": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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          "item": {
            "Field": "Recalling firm",
            "Value": "Encore Medical, LP",
            "Status": "recorded"
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          "item": {
            "Field": "Reason",
            "Value": "Package labeling for Altivate Reverse Torx Peripheral screw contains a different size  then actual  included product.",
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            "Field": "Initiated",
            "Value": "2025-05-28",
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          "item": {
            "Field": "Distribution pattern",
            "Value": "At time of quarantine:  RFK Medical Inc. Virginia (VA) CE102        506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm      2       506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm      1 Evolution Medical  North Dakota (ND), Minnesota (MN), Colorado (CO), Utah (UT) CE106        506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm      1       506-04-130 5039A1021 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm      4 Valor Medical Solutions South Texas (TX) CE118        506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm      6       506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm      17 Matrix Orthopedics Surgical Devices Dallas/Fort Worth, TX CE120        506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm       1 Joint Ventures Medical LLC Wisconsin (WI) CE121        506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm        24       506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm        1 WHISKEY TRAIL ORTHOPEDICS LLC - AUS Tennessee (TN)  CE123        506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm        8       506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm        4 McCants Medical, LLC Florida (FL) CE128        506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm        4       506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm        2 Florida Direct - FSW Medical Florida (FL) FL001        506-04-118 5033A1020 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 18mm        16       506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm        14       506-04-126 5037A1011 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm         6       506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm         72       506-04-130 5039A1015 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm         27       506-04-130 5039A1021 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm         65 Great Lakes Medical Illinois (IL) GL108        506-04-118 5033A1020 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 18mm         8       506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm         6       506-04-126 5037A1011 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm         2       506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm         14 Certus Medical LLC Indiana (IN) & Michigan (MI) GL112        506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm         14       506-04-126 5037A1011 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm         17       506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm          3       506-04-130 5039A1021 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm         23 I & S Medical  West Virginia (WV) & Kentucky (KY)  GL113        506-04-126 5037A1011 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm         1       506-04-130 5039A1015 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm         8 Osteo Solutions  Ohio (OH), Kentucky (KY),  GL114        506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm        15       506-04-126 5037A1011 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm        16       506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm         6       506-04-130 5039A1015 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm        32 Procore Medical, LLC North Carolina (NC)  MA102        506-04-118 5033A1020 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 18mm        1       506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm        14       506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm         2       506-04-130 5039A1015 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm        59 Medsource Rhode Island (RI), Massachusetts (MA) NE131        506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm        3       506-04-126 5037A1011 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm        12       506-04-126 5037A1017 ALTIVATE REVERSE TORX PER",
            "Status": "recorded"
          }
        }
      ]
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}