{
  "companyId": "55090",
  "slug": "arthrocare-corporation-55090",
  "name": "ArthroCare Corporation",
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    "last12Months": 2,
    "first": "1995-03-13",
    "latest": "2026-03-30"
  },
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    "openLast12Months": 0,
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        "resNumber": "Z-2999-2020",
        "productCode": "HXK",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2020-08-17",
        "reason": "Due to a supplier error where a portion of the raw material was inadvertently mixed. As a result, some needles may be made of commercially pure titanium as opposed to 304 stainless steel which does not meet the specification and could potentially break during use."
      },
      {
        "resNumber": "Z-3000-2020",
        "productCode": "GAT",
        "status": "Terminated",
        "recallClass": "Class II",
        "initiated": "2019-02-21",
        "reason": "The voluntary recall is being initiated due to a manufacturing error resulting in incorrect upper jaw dimensions, and the upper jaw could potentially disengage or detach during use."
      },
      {
        "resNumber": "Z-1321-2016",
        "productCode": "GEI",
        "status": "Terminated",
        "recallClass": "Class II",
        "initiated": "2016-03-03",
        "reason": "During functional testing of devices after real time aging, it was determined that product failed to meet shelf-life at the expiration date indicated on the product labels."
      },
      {
        "resNumber": "Z-0623-2016",
        "productCode": "GEI",
        "status": "Terminated",
        "recallClass": "Class II",
        "initiated": "2015-10-26",
        "reason": "There is cracking in the tray when the device is snapped into place. The crack is through the full thickness of the tray, compromising the sterile barrier."
      },
      {
        "resNumber": "Z-2105-2015",
        "productCode": "GEI",
        "status": "Terminated",
        "recallClass": "Class II",
        "initiated": "2015-06-02",
        "reason": "Wands inspected with the adaptor fixture were released to the field not meeting the dielectric (Hipot) specifications."
      }
    ]
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    "countries": [
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    {
      "code": "MBI",
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      "code": "HRX",
      "deviceName": "Arthroscope",
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    {
      "code": "NDN",
      "deviceName": "Cement, Bone, Vertebroplasty",
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    {
      "code": "FAS",
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    {
      "code": "HWC",
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    {
      "code": "OCW",
      "deviceName": "Endoscopic Tissue Approximation Device",
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      "medianReviewDays": 25
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    {
      "code": "EKZ",
      "deviceName": "Unit, Electrosurgical, And Accessories, Dental",
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      "medianReviewDays": 36
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    {
      "code": "GAT",
      "deviceName": "Suture, Nonabsorbable, Synthetic, Polyethylene",
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      "medianReviewDays": 58
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    {
      "code": "GEY",
      "deviceName": "Motor, Surgical Instrument, Ac-Powered",
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      "medianReviewDays": 30
    },
    {
      "code": "GXI",
      "deviceName": "Probe, Radiofrequency Lesion",
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    {
      "code": "KNS",
      "deviceName": "Unit, Electrosurgical, Endoscopic (With Or Without Accessories)",
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      "medianReviewDays": 29
    },
    {
      "code": "LRC",
      "deviceName": "Instrument, Ent Manual Surgical",
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    },
    {
      "code": "LYA",
      "deviceName": "Splint, Intranasal Septal",
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    {
      "code": "OAR",
      "deviceName": "Injector, Vertebroplasty (Does Not Contain Cement)",
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        "method": "normalised"
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      },
      {
        "name": "ArthroCare Corporation",
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      {
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        "method": "normalised"
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  "sources": {
    "clearances": "https://api.fda.gov/device/510k.json?search=applicant%3A%22ArthroCare%20Corporation%22",
    "recalls": "https://api.fda.gov/device/recall.json?search=recalling_firm%3A%22ArthroCare%20Corporation%22"
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  "retrievedAt": "2026-08-11T14:48:53.033Z"
}