{
  "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": "West Chester",
      "state": "PA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "64236",
      "recalling_firm": "Synthes USA HQ, Inc.",
      "address_1": "1302 Wrights Ln E",
      "address_2": "N/A",
      "postal_code": "19380-3417",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution - USA including CO, PA, TN, VA, TN, WA, and internationally to Czech Republic.",
      "recall_number": "Z-2282-2013",
      "product_description": "Synthes Oracle Spacer System Slap Hammer, Part Number 03.809.690, Lot Number 3723847    The Oracle Spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion combined with supplemental fixation. The Oracle Spacer is indicated as a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a diseased vertebral body resected or excised during partial and total vertebrectomy procedures or the treatment of tumor or trauma (i.e., fracture), to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of the collapsed vertebral body. The Slap Hammer, 03.809.690, is a dual sided device with two separate attachment options. The Slap Hammer allows a user (surgeon) to remove a previously placed trial implants.",
      "product_quantity": "27",
      "reason_for_recall": "This recall is being initiated in response to complaints received where it was reported that the proximal end of the Slap Hammer broke during use.",
      "recall_initiation_date": "20130111",
      "center_classification_date": "20130926",
      "termination_date": "20150831",
      "report_date": "20131002",
      "code_info": "Part number 03.809.690, Lot Number 6723847"
    }
  ]
}