{
  "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": "Bloomington",
      "state": "MN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "66057",
      "recalling_firm": "Tornier, Inc",
      "address_1": "10801 Nesbitt Ave S",
      "address_2": "N/A",
      "postal_code": "55437-3109",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": ".Worldwide Distribution - USA including Puerto Rico and  the states of AL, AZ, CA, CO,CT, FL, GA, IL, KY, MD, MA, MI, MN, NE, NJ, NC, OH, OR, PA and TX., and the countries of  CANADA, MEXICO, HONG KONG, SOUTH AFRICA, ARGENTINA, COLOMBIA, ISRAEL, AUSTRALIA, BELGIUM, FINLAND,FRANCE, GERMANY, ITALY, NETHERLANDS, SLOVENIA,  SPAIN, SWITZERLAND and UNITED KINGDOM",
      "recall_number": "Z-2199-2013",
      "product_description": "AEQUALIS Reversed II or AEQUALIS Reversed Fracture Impactor.  These products are contained within the  Aequalis reversed II Instrument set tray no.YKAD83 and the  Aequalis reversed fracture instrument set tray no.YKAD95. The items affected are  MWD21, MWD023, MWD024 and MWD025.    The impactor is an instrument used during shoulder arthroplasty; it is not implanted. The impactor is used to set the glenoid sphere, poly insert, spacer, and hemi adapter into place during surgery. The impactor is a two piece instrument which consists of a tip and a handle. The tip is made of plastic and metal that is pressed together for assembly.",
      "product_quantity": "2,298 (1045 US, 1253 OUS)",
      "reason_for_recall": "Following the identification of the disassociation of an impactor tip during surgery, Tornier is initiating a voluntary recall of all lots of Aequalis Reversed II and Reversed Fracture impactors.  Upon review of the event, Tornier determined that a redesign of the instrument was warranted.  These products are contained within the Aequalis Revered II instrument set tray no YKAD83 and the Aequalis R",
      "recall_initiation_date": "20130813",
      "center_classification_date": "20130913",
      "termination_date": "20150303",
      "report_date": "20130925",
      "code_info": "all lots",
      "more_code_info": ""
    }
  ]
}