{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Carlsbad",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "75337",
      "recalling_firm": "Alphatec Spine, Inc.",
      "address_1": "5830 El Camino Real",
      "address_2": "N/A",
      "postal_code": "92008-8816",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution - US Nationwide in the countries of Japan, UK, NSW, Spain.",
      "recall_number": "Z-0592-2017",
      "product_description": "Arsenal Spinal Fixation System, Set Screw, Part No. 47127  Product Usage:  Usage:  The Arsenal Spinal Fixation System is intended for posterior, non-cervical, spinal fixation as an adjunct to fusion for the treatment of degenerative disease, deformity, and trauma indications. The Arsenal System consists of a variety of shapes and sizes of rods, screws, hooks, connectors, and bridges that provide temporary internal fixation and stabilization during bone graft healing and/or fusion mass development. The screws, hooks, connectors, and bridges are manufactured from surgical grade titanium alloy (Ti-6AI-4V ELI). The rods are available in commercially pure titanium, titanium alloy, and cobalt chrome (CP Ti Grade 4, Ti-6Al-4V ELI, and Co-28Cr-6Mo).",
      "product_quantity": "16,972 units",
      "reason_for_recall": "Alphatec Spine is recalling the Arsenal Spinal Fixation System Set Screw due to a trend in set screw postoperative disengagement from the screw body.",
      "recall_initiation_date": "20161005",
      "center_classification_date": "20161116",
      "termination_date": "20170217",
      "report_date": "20161123",
      "code_info": "Lot Numbers  695621   696252   697128   698437   700943   7689801  695622   696253   697129   698438   700944   7689802  695623   696254   697130   698439   700945   7689803  695624   696255   697131   698440   701393   7689804  695625   696256   697520   698441   701394   695626   696257   697521   698442   701395   695627   696258   697522   700611   701396   696124   696558   697523   700612   701397   696125   696574   697524   700613   701398  696126   696575   698433   700614   701399  696127   696576   698434   700615   701400  696128   696577   698435   700941   701401  696251   697127   698436   700942   701851  7878901  7829602  7766302  7766301"
    }
  ]
}