{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Center Valley",
      "address_1": "3773 Corporate Pkwy",
      "reason_for_recall": "Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of the inner packaging.",
      "address_2": "",
      "product_quantity": "",
      "code_info": "All product with old packaging configuration. New packaging configuration begins with Lot 52533610.",
      "center_classification_date": "20200313",
      "distribution_pattern": "Worldwide distribution - US Nationwide distribution in the states of AL, CA, CO, FL, GA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, OH, OK, OR, PA, TN, TX, UT, WA and countries of Saudi Arabia, Utd. Arab Emir., Argentina, Austria, Australia, Bosnia-Herz., Bulgaria, Brazil, Switzerland, Chile, China, Colombia,   Costa Rica, Cuba, Czech Republic, Germany, Algeria, Ecuador, Estonia, Spain, United Kingdom, Georgia,   Greece, Hong Kong, Croatia, Hungary, Indonesia, Ireland, Israel, India, Iraq, Iran, Italy, Jordan, Japan,   South Korea, Lithuania, Latvia, Libya, Moldavia, Mexico, Malaysia, Nigeria, Netherlands, Poland, Portugal, Paraguay, Russian Fed., Singapore, El Salvador, Thailand, Turkey, Ukraine, South Africa.",
      "state": "PA",
      "product_description": "COLUMBUS REV F TIBIA OFFSET CEMENTED, Knee implant components, various sizes, model nos.  NR068K  NR068Z  NR070K  NR070Z  NR071K  NR071Z  NR072K  NR072Z  NR073K  NR073Z  NR074K  NR074Z  NR075K  NR075Z  NR076K  NR076Z  NR077K  NR077Z  NR078K  NR078Z  NR079K  NR079Z  Product Usage: Tibia-Plateaus are part of implants in the group of knee endoprosthetics. For these implant parts there are cemented and cement-free versions as well as versions with zirconium nitride multi layer.",
      "report_date": "20200325",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Aesculap Implant Systems LLC",
      "recall_number": "Z-1482-2020",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "84865",
      "termination_date": "20210922",
      "more_code_info": "",
      "recall_initiation_date": "20200121",
      "postal_code": "18034-8217",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}