{
  "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": "2026-04-29",
    "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": "69533",
      "recalling_firm": "Synthes, 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.",
      "recall_number": "Z-1009-2015",
      "product_description": "The Synthes Mandible External Fixator; all lots of part nos.:     04.305.003  04.305.004  04.305.005  04.305.010  04.305.011  04.305.012  03.305.006  04.305.100  04.305.101  04.305.102  04.305.103  04.305.128  04.305.130  04.305.134  04.305.138  04.305.140  04.305.142  03.305.105  03.305.500  03.305.500S    Intended to stabilize and provide treatment for fractures of the maxillofacial area, including severe open mandibular fractures, highly comminuted closed fractures, nonunions and delayed unions (especially associated with infection), fractures associated with infections, tumor resections, facial deformity corrections, gunshot wounds, pan facial fractures, burn maintenance, and bone grafting defects.",
      "product_quantity": "43159",
      "reason_for_recall": "Under new testing protocols for MR Environment safety and compatibility, metal devices are no longer designated MR Safe. Some components in the CMF Mandible External Fixator Systems were labeled and/or etched with information indicating they are MR Safe.  They can no longer be labeled MR Safe.",
      "recall_initiation_date": "20141017",
      "center_classification_date": "20150123",
      "termination_date": "20160818",
      "report_date": "20150204",
      "code_info": "All lots of part nos.:   04.305.003  04.305.004  04.305.005  04.305.010  04.305.011  04.305.012  03.305.006  04.305.100  04.305.101  04.305.102  04.305.103  04.305.128  04.305.130  04.305.134  04.305.138  04.305.140  04.305.142  03.305.105"
    }
  ]
}