{
  "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": [
    {
      "status": "Terminated",
      "city": "Mahwah",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "70994",
      "recalling_firm": "Stryker Howmedica Osteonics Corp.",
      "address_1": "325 Corporate Dr",
      "address_2": "N/A",
      "postal_code": "07430-2006",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Worldwide Distribution: US (nationwide) including PR and countries of: Australia, Canada, China, Brazil, France, Hong Kong, India, Italy, Mexico, Netherlands, Singapore, South Africa, Sweden, and Spain.",
      "recall_number": "Z-1633-2015",
      "product_description": "Stryker Howmedica Osteonics RESTORATION Acetabular Augment System; Howmedica Osteonics Corp.,  A subsidiary of Stryker Corporation Made in USA Sterile.    Hip prosthesis component.  The RESTORATION Acetabular Wedge Augments provide multiple options to address the wide range of bone deficiencies encountered in acetabular revision. The augments provide support for the shell in the acetabulum with superior and/or posterior defects.",
      "product_quantity": "1,147 in total",
      "reason_for_recall": "The peel strength of the inner blister may have been below internal validated requirements.  The strength of the seal is directly related to long term shelf life of the sterile barrier.",
      "recall_initiation_date": "20140815",
      "center_classification_date": "20150519",
      "termination_date": "20180105",
      "report_date": "20150527",
      "code_info": "Ref #:Lot Number - 5096-4615:MMR8M8; 5096-4615:MMRLYD; 5096-4615:MNAYT7; 5096-5015:MMPO6K; 5096-5015:MMRWOJ; 5096-5015:MNADVA; 5096-5815:MNA40L;  5096-5820:MMR6HX;  5096-5825:MMRLD7;  5096-6225:MMPWO5;  5096-6225:MMRM2Y;  5096-6625:MMNM07"
    }
  ]
}