{
  "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": "Warsaw",
      "address_1": "345 E Main St",
      "reason_for_recall": "Two complaints were received in which it was reported that the stem would not lock into the tibia.  Evaluation of the returned device found that the stemmed portion of the tibial plate would not hold the stem as the connection was too loose. The taper diameter was found to be oversized by .010\u001d.",
      "address_2": "",
      "product_quantity": "128 units",
      "code_info": "00-5980-037-02; lot 6228417",
      "center_classification_date": "20131211",
      "distribution_pattern": "Worldwide Distribution - USA (nationwide) including the states of CA, IN, OH, GA, WI, IA, NE, NJ, PA, NY, MD, NC, AZ, NM, TX, CO, IL, AL, MI, WA, FL and KS, and the countries of  China, Japan and Taiwan.",
      "state": "IN",
      "product_description": "NexGen¿ Complete Knee Solutions Stemmed Tibial Component Precoat    NexGen Tibial Baseplates are part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis. The device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis; Collagen disorders, and/or avascular necrosis of the femoral condyle; Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy; Moderate valgus, varus, or flexion deformities.",
      "report_date": "20131218",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Zimmer, Inc.",
      "recall_number": "Z-0480-2014",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "66714",
      "termination_date": "20150430",
      "more_code_info": "",
      "recall_initiation_date": "20131031",
      "postal_code": "46580-2746",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}