{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Orange",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "66110",
      "recalling_firm": "Sybron Dental Specialties",
      "address_1": "1717 W Collins Ave",
      "address_2": "N/A",
      "postal_code": "92867-5422",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution - USA Nationwide and the countries of Australia, Canada, and EU.",
      "recall_number": "Z-2195-2013",
      "product_description": "AOA Mini RPE Screw Assembly , a component of  Herbst, MARA and Fixed Metal devices.    Product Usage:  AOA Mini RPE Screw Assembly is a component of Herbst, MARA and Fixed Metal devices; removable functional appliances that are to modify the growth of the jaws in a prescribed growth pattern, however, this category is generally attached to the patient\u0019s upper and lower molars or bicuspids by means of temporary stainless steel crowns or orthodontic bands. Retainer, Screw Expansion, Orthodontic.",
      "product_quantity": "1,091",
      "reason_for_recall": "The firm initiated the recall of AOA Mini RPE Screw Assembly, because it may be missing a complete weld joining one side of the arm with the screw body. Herbst, MARA and Fixed Metal devices may be affected, because they contain an AOA Mini RPE Screw Assembly.",
      "recall_initiation_date": "20130606",
      "center_classification_date": "20130912",
      "termination_date": "20130913",
      "report_date": "20130918",
      "code_info": "The AOA Mini RPE Screw Assembly is a component used in customized palate  expander appliances assembled by prescription. The affected assembly may be  found in products listed in the table below:    Product Description:  Herbst Bite Jumper  Herbst Appliance Acrylic Splint  M.A.R.A. (Mandibular Anterior Reposi tioning Appliance)  Rapid Palatal Expander  Lower Expander  DeLuke Bonded Frameless Expander  Haas Expander  AOA Mini Rapid Palatal Expander  Dischinger Lower Expansion Appliance  Tracy/Hilgers MDA Appliance  Distal Jet Molar Uprighter    Part  Number:  3000-0010  3000-0011  3000-0012  3000-0040  3000-0042  3000-0045  3000-0046  3000-0047  3000-0050  3000-0094  3000-0097    Lot Number:  \"All Devices Manufactured from April 3, 2013  to May 21, 2013\"",
      "more_code_info": ""
    }
  ]
}