{
  "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": "Portage",
      "state": "MI",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "74582",
      "recalling_firm": "Stryker Instruments Div. of Stryker Corporation",
      "address_1": "4100 E Milham Ave",
      "address_2": "N/A",
      "postal_code": "49002-9704",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution.  US nationwide, France, Netherlands, Spain, Italy, Canada, Israel, Romania, Switzerland, and United Kingdom.",
      "recall_number": "Z-2536-2016",
      "product_description": "Stryker AutoPlex System.  Model Numbers  0607-687-000, 0605-887-000, 0605-687-000, and  0605-683-000.  For bone cement.    Stryker AutoPlex System kits contain a cement mixer, cement injector, funnel, and an extension tube assembly whereby bone cement powder and liquid monomer are mixed inside a chamber and transferred into a cement injector automatically. The bone cement is then dispensed directly into a fracture site using the cement injector and introducer needle combination.",
      "product_quantity": "4,841 boxes (9,682 units)",
      "reason_for_recall": "The Piston Head can become separated from the Delivery Piston, blocking the injection assembly Valve resulting in a cement backflow towards the injector handle.  Potential for delay in surgery if additional cement needs to be prepared for the injection procedure.",
      "recall_initiation_date": "20160614",
      "center_classification_date": "20160815",
      "termination_date": "20170327",
      "report_date": "20160824",
      "code_info": "Model Number(s):  0607-687-000  0605-887-000  0605-687-000  0605-683-000    0607-687-000 \u0013 Lot numbers: 16021012, 16027022, 16049012, 16061012,  16092012, 16107012, 16022012, 16028012, 16049022, 16063012, 16098012,  16109012, 16025012, 16028022, 16049032, 16063022, 16100012, 16109022,  16025022, 16033012, 16053012, 16070012, 16104012, 16113022, 16026012,  16041012, 16056012, 16070022, 16104022, 16113032, 16026022, 16048012,  16056022, 16074012, 16105012, 16118012, 16027012, 16048022, 16060012,  16088012, 16106012, 16118022  0605-887-000 \u0013 Lot numbers: 16041012, 16040012, 16050012, 16057012,  16069012, 16078012, 16104012, 16112012, 16124012  0605-687-000 \u0013 Lot numbers: 16041012, 16047012, 16111012  0605-683-000 \u0013 Lot numbers: 16071012"
    }
  ]
}