{
  "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": "Warsaw",
      "state": "IN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "66500",
      "recalling_firm": "Zimmer, Inc.",
      "address_1": "345 E Main St",
      "address_2": "",
      "postal_code": "46580-2746",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution-USA (nationwide) and the countries of  Belgium, Canada, Canary Islands, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Korea, Luxemburg, Netherlands, New Zealand, Norway, Portugal Reunion, Russian Federation, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, Taiwan, Thailand,  and United Kingdom.",
      "recall_number": "Z-1018-2014",
      "product_description": "MODULAR AUSTIN MOORE FENE. Item codes starting with 45502001, 455503001 and 455504001",
      "product_quantity": "7,044,680 total",
      "reason_for_recall": "Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations.",
      "recall_initiation_date": "20131011",
      "center_classification_date": "20140220",
      "termination_date": "20170414",
      "report_date": "20140226",
      "code_info": "365614  369469  60101996  60101997  60156488  60156489  60178356  60187896  60202868  60202869  60257213  60261647  60266457  60273995  60273996  60324337  60411690  60411691  60428980  60457742  60474620  60474621  60474622  60646263  60646264  60646265  60708475  60797297  60822088  60867060  60899017  60899018  60945798  61104294  61199990  61222220  61282924  61293845  61320383  61336983  61336985  61522992  61550876  61555656  61664260  365612  369617  370353  370412  60065984  60113194  60135098  60135109  60156491  60179688  60242116  60242117  60273997  60294371  60345749  60457743  60600426  60646268  60708476  60803408  60846356  60899019  60945799  60979573  61172283  61199988  61282925  61320379  61339628  61460816  61550877  61664258  60242118  60324338  60428996  60474623  61222221",
      "more_code_info": ""
    }
  ]
}