{
  "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": "Warsaw",
      "state": "IN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "62110",
      "recalling_firm": "Zimmer, Inc.",
      "address_1": "345 E Main St",
      "address_2": "N/A",
      "postal_code": "46580-2746",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Worldwide Distribution - USA (nationwide) and internationally to Canada, Mexico, South America, Europe, Puerto Rico, China, and Korea.",
      "recall_number": "Z-2484-2012",
      "product_description": "00780304001 MIS 12/14 Slotted Femoral Head Provisional -3.5X36  00780304002 MIS 12/14 Slotted Femoral Head Provisional +0X36  00780304003 MIS 12/14 Slotted Femoral Head Provisional +3.5X36  00780304004 MIS 12/14 Slotted Femoral Head Provisional +7X36  00780304005 MIS 12/14 Slotted Femoral Head Provisional +10.5X36    The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty.",
      "product_quantity": "231,641 all lots, all sizes",
      "reason_for_recall": "Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS) and the mating components (ie stems and provisional femoral necks), in some cases alleging the fit was too loose and in other cases, alleging the fit was too tight.  Intraoperative dislodging of the provisional head and the provisional head being left in-vivo after separating from mating comp",
      "recall_initiation_date": "20110401",
      "center_classification_date": "20120928",
      "termination_date": "20140516",
      "report_date": "20121010",
      "code_info": "All lots including lot 78939000 (1/7/2002) to present"
    }
  ]
}