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        "reason": "Product incorrectly labelled."
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        "reason": "The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the implant material properties."
      },
      {
        "resNumber": "Z-1264-2023",
        "productCode": "KRO",
        "status": "Open, Classified",
        "recallClass": "Class II",
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        "reason": "The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the implant material properties."
      },
      {
        "resNumber": "Z-1265-2023",
        "productCode": "KRO",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2023-02-15",
        "reason": "The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the implant material properties."
      },
      {
        "resNumber": "Z-1266-2023",
        "productCode": "KRO",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2023-02-15",
        "reason": "The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the implant material properties."
      }
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    "countries": [
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    {
      "code": "HRS",
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    {
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    {
      "code": "KTT",
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    {
      "code": "PHX",
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    {
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    {
      "code": "HAW",
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      "code": "HSD",
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      "code": "FTM",
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    {
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    {
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    {
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    {
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