{
  "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": "65668",
      "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": "US distribution: PA only.  .",
      "recall_number": "Z-1821-2013",
      "product_description": "Synthes Synapse SD Drill Guide, Part Number SD389.477, Lot Number 6913900    Indicated for Hooks, Plate/Rods, Rods and Screws when intended to promote fusion of the cervical spine fusion of the cervical spine and occipitocervical junction (occiput-T3), the plate/rod, rod, hook and screw (3.2 mm cortex) components of the Synthes Cervifix; Axon and Synapse Systems are indicated for the following: -Degenerative Disk Disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies); -Spondylolisthesis; -Spinal Stenosis; -Fracture/dislocation; -Atlantoaxial fracture with instability; -Occipitocervical dislocation; -Revision of previous cervical spine surgery; and -Tumo",
      "product_quantity": "2",
      "reason_for_recall": "A complaint was received from the field, that the drill guide was etched incorrectly, 12mm etch instead of 18mm drill guide.  The firm identified that this constituted a field action and retrospectively reported this action.",
      "recall_initiation_date": "20121012",
      "center_classification_date": "20130729",
      "termination_date": "20150611",
      "report_date": "20130807",
      "code_info": "Part Number SD389.477, Lot Number 6913900",
      "more_code_info": ""
    }
  ]
}