{
  "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": "2026-04-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Warsaw",
      "address_1": "700 Orthopaedic Dr",
      "reason_for_recall": "The SIGMA¿ HP PFJ Cemented Trochlear Implants, a standalone component of the partial knee system is being recalled based on elevated revision rates observed as part of the company s post market surveillance process.",
      "address_2": "",
      "product_quantity": "2110",
      "code_info": "All lots",
      "center_classification_date": "20180327",
      "distribution_pattern": "Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico and to the states of :  AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and the District of Columbia., and to the countries of :  Australia, Austria, Belgium, Canada, Croatia, Denmark, Finland, France, Germany, India, Ireland, Italy, Korea, Luxembourg, Malaysia, Netherlands, Portugal, Singapore, Slovakia. Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, and United Kingdom.",
      "state": "IN",
      "product_description": "(1) Sigma HP Cemented Trochlea Size 1 Narrow Left, Catalog Number: 102403100, GTIN: 10603295001614; (2) Sigma HP Cemented Trochlea Size 2 Narrow Left, Catalog Number: 102403200, GTIN: 10603295001621; (3) Sigma HP Cemented Trochlea Size 3 Narrow Left, Catalog Number: 102403300, GTIN: 10603295001638; (4) Sigma HP Cemented Trochlea Size 4 Narrow Left, Catalog Number: 102403400, GTIN: 10603295001645; (5) Sigma HP Cemented Trochlea Size 5 Narrow Left, Catalog Number: 102403500, GTIN: 10603295001652; (6) Sigma HP Cemented Trochlea Size 1 Narrow Right, Catalog Number: 102404100, GTIN: 10603295001669; (7) Sigma HP Cemented Trochlea Size 2 Narrow Right, Catalog Number: 102404200, GTIN: 10603295001676; (8) Sigma HP Cemented Trochlea Size 3 Narrow Right, Catalog Number: 102404300, GTIN: 10603295001683; (9) Sigma HP Cemented Trochlea Size 4 Narrow Right, Catalog Number: 102404400, GTIN: 10603295001690; (10) Sigma HP Cemented Trochlea Size 5 Narrow Right, Catalog Number: 102404500, GTIN: 10603295001706",
      "report_date": "20180404",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "DePuy Orthopaedics, Inc.",
      "recall_number": "Z-1219-2018",
      "initial_firm_notification": "E-Mail",
      "product_type": "Devices",
      "event_id": "79475",
      "termination_date": "20200401",
      "more_code_info": "",
      "recall_initiation_date": "20171221",
      "postal_code": "46582-3994",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}