{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-09-17",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 9
    }
  },
  "results": [
    {
      "cfres_id": "197297",
      "product_res_number": "Z-0916-2023",
      "event_date_initiated": "2022-12-07",
      "event_date_posted": "2023-01-07",
      "recall_status": "Open, Classified",
      "res_event_number": "91231",
      "product_code": "HBC",
      "k_numbers": [
        "K011444",
        "K133604"
      ],
      "product_description": "6.5 cm Adult Rotating Craniotome Attachment. Use with XMax, microMax, and eMax Systems.\n\nRef: CRANI-A\n\nIntended for cutting and shaping bone including the spine and cranium",
      "code_info": "GTIN: 00845384001720\nAll lots",
      "firm_fei_number": "1045834",
      "recalling_firm": "The Anspach Effort, Inc.",
      "address_1": "4500 Riverside Dr",
      "city": "Palm Beach Gardens",
      "state": "FL",
      "postal_code": "33410-4235",
      "additional_info_contact": "SAME\n561-627-1080",
      "reason_for_recall": "Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommended inspection intervals provided in the IFU may result in serious patient injury",
      "root_cause_description": "Under Investigation by firm",
      "action": "DePuy Synthes initiated \"URGENT: MEDICAL DEVICE CORRECTION (Notification)\" via UPS on 12/07/22. Letter states reason for recall, health risk an action to be taken. The customers were instructed to do the following:\nReview your inventory and make a plan to follow the suggested manufacturer inspection interval of 12 months associated with your product, as specified in the IFU.\n\" Forward this notice to anyone in your facility that needs to be informed (i.e., those who manage, transport, store, stock, or use the subject products).\n\" If any of the subject products have been forwarded to another facility, contact that facility and provide them with this notice.\n\" Once this notification is received, please complete, sign, and return the attached Business Response Form (page 3 of this letter) via Fax: 877-496-5042 or Scan/email: Synthes3606@sedgwick.com within 3 business days of receipt of this notification.\n\nContact your Product Support Team through email at ra-dpyus-prodsupport@its.jnj.com or via phone at 1-800.327.6887, option #2 for additional support as needed.",
      "product_quantity": "6059 units in total",
      "distribution_pattern": "US Nationwide and OUS Foreign: \nImpacted Foreign Countries\nAustralia\nBangladesh\nChina\nHongkong\nIndia\nIndonesia\nJapan\nKorea (Republic of)\nMalaysia\nNew Zealand\nPhilippines\nSingapore\nTaiwan, Province of China\nThailand\nAngola\nAustria\nBelgium\nCroatia\nCyprus\nCzech Republic\nDenmark\nEquatorial Guinea\nFinland\nFrance & French Guiana\nGeorgia\nGermany\nGreece\nHungary\nIsrael\nItaly\nKenya\nKuwait\nLebanon\nLithuania\nMacedonia\nMauritius\nMorocco\nNetherlands\nPoland\nPortugal\nSaudi Arabia\nSlovakia\nSouth Africa\nSpain\nSweden\nSwitzerland\nTurkey\nUnited Arab Emirates\nUnited Kingdom of Great Britain and Northern Ireland\nArgentina\nBolivia\nBrazil\nChile\nColombia\nCosta Rica\nJamaica\nMexico\nPanama\nPeru\nCanada",
      "openfda": {
        "k_number": [
          "K130497",
          "K173066",
          "K083112",
          "K232938",
          "K133604",
          "K254174",
          "K193630",
          "K213697",
          "K053526",
          "K170312",
          "K132264",
          "K233153",
          "K022986",
          "K002523",
          "K972857",
          "K862989",
          "K183515",
          "K012457",
          "K012453",
          "K080444",
          "K163565",
          "K152960",
          "K812436",
          "K011444",
          "K060260",
          "K003612",
          "K220485"
        ],
        "registration_number": [
          "3007958831",
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        "fei_number": [
          "1000139790",
          "3007958831",
          "1000138054",
          "3002806315",
          "3015453963",
          "3025764223",
          "2916714",
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          "3009417901",
          "1000306340",
          "3007997036",
          "1000517638",
          "1625507",
          "1048735",
          "3003128516",
          "3004598644",
          "1526534",
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          "3007305485",
          "3017210488",
          "1526611",
          "3012607373",
          "3010163695",
          "3033509898"
        ],
        "device_name": "Motor, Drill, Electric",
        "medical_specialty_description": "Neurology",
        "regulation_number": "882.4360",
        "device_class": "2"
      }
    }
  ]
}