{
  "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": [
    {
      "country": "United States",
      "city": "Portage",
      "address_1": "4100 E Milham Ave",
      "reason_for_recall": "On March 14, 2013 a Work Order was opened for 120 units (20 boxes) of the Acetabular Pressurizer (P/N 0206-522-000 Rev. H). On March 15, 2013, when the product was going to be placed in the pouch to be sealed, the manufacturing operator noticed that some assemblies were cracked. As a result of the injection pressure of the cement gun, a cracked tiplet may release from the Hub during cement applica",
      "address_2": "",
      "product_quantity": "87 boxes (522 each)",
      "code_info": "Part number: 0206-522-000 and lots: 08183012, 08310012, 09237012, 10243012, 11109012, 11353012, and 12216012",
      "center_classification_date": "20131114",
      "distribution_pattern": "Worldwide distribution: US (nationwide) including states of: TX, FL, IL, IA, ND, WI, VA, and NJ.; and countries of: CANADA, POLAND and SWITZERLAND.",
      "state": "MI",
      "product_description": "Acetabular Pressurizer; single use and six units per box.    The Acetabular Pressurizer 0206-522-000 is an accessory to the  Advanced Cement Mixer (ACM). The Acetabular Pressurizer  Tiplet P/N 0206-522-012 is sealed in a two pouches, sterilized, and labeled as part number 0206-522-000.    This Acetabular Pressurizer is an accessory used to pressurize the cement applied to the prosthesis to be implanted during the surgery. The Acetabular Pressurizer is an injection molded component made with resin material DOW HDPD 10462N which is a rigid plastic once it is molded.",
      "report_date": "20131120",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Stryker Instruments Div. of Stryker Corporation",
      "recall_number": "Z-0280-2014",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "66444",
      "termination_date": "20140210",
      "more_code_info": "",
      "recall_initiation_date": "20131101",
      "postal_code": "49002-9704",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}