{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "140745",
      "product_res_number": "Z-0192-2016",
      "event_date_initiated": "2015-10-07",
      "event_date_created": "2015-10-30",
      "recall_status": "Terminated",
      "event_date_terminated": "2016-08-26",
      "res_event_number": "72360",
      "product_code": "EZX",
      "product_description": "Synthes Threaded Plate Holder- Long for 3.5mm Locking Hold; Part Numbers  324.031.\t\n\nThe Threaded Plate Holder can be used as an aid to position the plate on the bone. The plate holder may also function as an insertion handle for use with minimally invasive plating techniques.  The plate may be temporarily held in place with standard plate holding forceps or the push-pull reduction device.",
      "code_info": "Threaded Plate Holder-Long for 3.5mm Locking Hole\t Part Numbers\tLot Numbers    324.031\t                          8225613",
      "firm_fei_number": "3008812560",
      "recalling_firm": "Synthes (USA) Products LLC",
      "address_1": "1301 Goshen Pkwy",
      "city": "West Chester",
      "state": "PA",
      "postal_code": "19380-5986",
      "additional_info_contact": "610-719-6500",
      "reason_for_recall": "The affected part number and lot listed above is incorrectly etched with the wrong part number and may not fit into a Small Fragment Plate.",
      "root_cause_description": "Mixed-up of materials/components",
      "action": "The firm, DePuy Synthes, sent an \"URGENT NOTICE: MEDICAL DEVICE RECALL\" letter dated 10/5/2015 to its customers. The letter described the product, problem and actions to be taken.  The customers were instructed to do the following:\n\"  Call DePuy Synthes at 1-800-479-6329 to obtain a Return Authorization (RA) Number and replacement product(s).\n\"  Complete the Verification Section (page 3 of this letter) by checking the appropriate box indicating affected product has been located.  Also, please indicate the number of devices found and note the Return Authorization Number.  Please include your name, title, address, telephone number and signature in the spaces provided.\n\"  Return the Verification Section (page 3 of this letter) with the product to: Credit/Returns, DePuy Synthes, 1101 Synthes Avenue, Monument, CO  80132. Even if you do not have any product.\n\"  Send a copy of the completed Verification Section by: Fax:  844-721-3048 or\nScan/email:  Synthes4704@stericycle.com.\n\"   Note: If the Verification Section is answered on behalf of more than one facility and/or individual, please clearly indicate the name and address of the facility and/or individual on page 3 of the notification.\n\nIf you have any questions, please call 610-719-5450 or contact your DePuy Synthes Sales Consultant.",
      "product_quantity": "25",
      "distribution_pattern": "Worldwide distribution: US (nationwide) and country of: Canada.",
      "openfda": {
        "k_number": [
          "K945027",
          "K983766",
          "K896369",
          "K024169",
          "K900138",
          "K890601",
          "K032282",
          "K020853",
          "K063461",
          "K014200",
          "K023882",
          "K032344"
        ],
        "registration_number": [
          "1526534",
          "1824199",
          "3015831087",
          "3018094310",
          "8031010",
          "3009941480",
          "1423662",
          "3014725904",
          "3009417901",
          "3004464325",
          "3015440604",
          "3008114965",
          "3008868758",
          "2135156",
          "2024024",
          "3015212339",
          "1526439",
          "3008812560",
          "1030489",
          "1226425",
          "3015531529",
          "8010177",
          "1835831",
          "3006128100",
          "3000270450",
          "2647346"
        ],
        "fei_number": [
          "1526534",
          "1824199",
          "3015831087",
          "3018094310",
          "3003179719",
          "3001814066",
          "3009941480",
          "1000477302",
          "3014725904",
          "1000185904",
          "3009417901",
          "3004464325",
          "3015440604",
          "3008114965",
          "3008868758",
          "3003018882",
          "2024024",
          "3000215273",
          "3015212339",
          "1526439",
          "3008812560",
          "3015531529",
          "3002821504",
          "3006128100",
          "3000270450",
          "2647346"
        ],
        "device_name": "Mesh, Surgical, Metal",
        "medical_specialty_description": "General, Plastic Surgery",
        "regulation_number": "878.3300",
        "device_class": "2"
      }
    }
  ]
}