{
  "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": "750 Trade Centre Way",
      "reason_for_recall": "Stryker received reports of the desiccant bag in the kit leaking silica gel granulate.  This could increase exposure to anesthesia during surgical delay up to 60 minutes or inadvertent implantation of silica gel granulate which could cause  foreign body reaction  including inflammation and might lead to the need for revision surgery.",
      "address_2": "Ste 200",
      "product_quantity": "12,719",
      "code_info": "Part 79-43903, Lot: IC01116, IC01130, IC01204, IC01233, IC01238  Part 79-43905 Lot: IC01084, IC01085, IC01086, IC01093, IC01123, IC01150, IC01166, IC01167, IC01168, IC01180, IC01188, IC01189, IC01190, IC01198, IC01199, IC01200, IC01213, IC01214, IC01229,  IC01230, IC01239, IC01240, IC01245, IC01246, IC01270  Part 79-43910 Lot:  IC01087, IC01090, IC01091, IC01153, IC01154, IC01163, IC01164, IC01165, IC01179, IC01183, IC01184, IC01201, IC01202, IC01203, IC01231, IC01243, IC01244, IC01248, IC01249, IC01261, IC01264,     Part 79-43015 Lot:  IC01100, IC01114, IC01161, IC01162, IC01182, IC01211, IC01212, IC01227, IC01228, IC01241, IC01242, IC01252, IC01253, IC01254, IC01267    Part 397003 Lot:  IC01092, IC01101, IC01102, IC01103, IC01104, IC01105, IC01106, IC01107, IC01115, IC01127, IC01131, IC01205, IC01220, IC01232, IC01234    Part 397005 Lot:  IC01088, IC01094, IC01095, IC01096, IC01097, IC01098, IC01110, IC01111, IC01118, IC01119, IC01120, IC01132, IC01133, IC01134,  IC01135, IC01136, IC01137, IC01147, IC01148, IC01149, IC01158, IC01159, IC01160, IC01171, IC01172, IC01181, IC01193, IC01194,  IC01195, IC01196, IC01223, IC01224, IC01247Part 79-43910 Lot: IC01087, IC01090, IC01091, IC01153, IC01154    Part 397010 Lot: IC01099, IC01108, IC01109, IC01112, IC01121, IC01138, IC01139, IC01140, IC01141, IC01151, IC01152, IC01155, IC01156, IC01157,  IC01173, IC01174, IC01191, IC01192, IC01197, IC01210, IC01216, IC01219, IC01225, IC01226, IC01250, IC01251, IC01263, IC01266, IC01301    Part 397015 Lot: IC01113, IC01122, IC01124, IC01125, IC01142, IC01143, IC01144, IC01145, IC01146, IC01169, IC01170, IC01177, IC01178, IC01185,  IC01186, IC01187, IC01206, IC01207, IC01208, IC01209, IC01217, IC01218, IC01221, IC01222, IC01265",
      "center_classification_date": "20130826",
      "distribution_pattern": "Worldwide Distribution - USA (nationwide) including the countries through Stryker Distribution: Austria, Belgium, Denmark, Estonia, Finland, France, Germany, Ireland, Italy, Latvia, Luxembourg, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Spain, Sweden, Switzerland, United Kingdom, Argentina, Australia, Brazil, Jordan, Kingdom of Saudi Arabia, Kuwait, Latin America (others), New Zealand, Russia, Singapore, South Africa, and United Arabian Emirates.",
      "state": "MI",
      "product_description": "Stryker Part Numbers 79-43903 (3cc), 79-43905 (5cc), 79-43910 (10 cc), 79-43915 (15cc),  397003 (3cc), 397005 (5cc), 397010 (10 cc), 397015 (15 cc) HydroSet Injectable HA Bone Substitute Sterile R/EO, nonpyrogenic,  Product of Ireland    Stryker Injectable Cement is a self-setting, calcium phosphate cement intended for use in the repair of neurosurgical burr holes, contiguous craniotomy cuts and other cranial defects as well as in the augmentation or restoration of bony contour in the craniofacial skeleton. The powder is mixed with the sodium phosphate/PVP solution provided in the kit and loaded into the empty cement delivery syringe to be applied directly to the site for void filling or augmentation.",
      "report_date": "20130904",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Stryker Craniomaxillofacial Division",
      "recall_number": "Z-2054-2013",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "65787",
      "termination_date": "20140417",
      "more_code_info": "",
      "recall_initiation_date": "20130730",
      "postal_code": "49002-0482",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}