{
  "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": "63066",
      "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": "Letter",
      "distribution_pattern": "Worldwide distribution: USA (nationwide) and countries of:  Asia, Barbados, Canada, Europe, Mexico, Puerto Rico, San Juan, and South America.",
      "recall_number": "Z-0396-2013",
      "product_description": "00780302601 MIS 12/14 Slotted Femoral Head Provisional -3.5X26  00780302602 MIS 12/14 Slotted Femoral Head Provisional +0X26  00780302603 MIS 12/14 Slotted Femoral Head Provisional +3.5X26  00780302604 MIS 12/14 Slotted Femoral Head Provisional +7X26  00780302605 MIS 12/14 Slotted Femoral Head Provisional +10.5X26    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": "56,516 all lots, all sizes",
      "reason_for_recall": "Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been enhanced to inform users that the head may become difficult to visually locate if it becomes displaced deep or medial to the iliopsoas tendon and provide non-invasive imaging methods that can be used to locate the head.  To reduce incidence of sub-optimal fit between provisional femoral heads and the mat",
      "recall_initiation_date": "20101010",
      "center_classification_date": "20121119",
      "termination_date": "20140430",
      "report_date": "20121128",
      "code_info": "All lots distributed from lot 69998600 (2/20/1996) to present"
    }
  ]
}