{
  "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-1041-2014",
      "product_description": "2.7 X 6 CORT SCREW/SELFTA  2.7 X 7 CORT SCREW/SELFTA  2.7 X 8 CORT SCREW/SELFTA  2.7 X 9 CORT SCREW/SELFTA  2.7 X 10 CORT SCREW/SELFT  2.7 X 12 CORT SCREW/SELFT  2.7 X 14 CORT SCREW/SELFT  2.7 X 16 CORT SCREW/SELFT  2.7 X 18 CORT SCREW/SELFT  2.7 X 20 CORT SCREW/SELFT  2.7 X 22 CORT SCREW/SELFT  2.7 X 24 CORT SCREW/SELFT  2.7 X 26 CORT SCREW/SELFT  2.7 X 28 CORT SCREW/SELFT  2.7 X 30 CORT SCREW/SELFT  2.7 X 32 CORT SCREW/SELFT  2.7 X 34 CORT SCREW/SELFT  2.7 X 36 CORT SCREW/SELFT  2.7 X 38 CORT SCREW/SELFT  2.7 X 40 CORT SCREW/SELFT  2.7 X 42 CORT SCREW/SELFT  2.7 X 44 CORT SCREW/SELFT  2.7 X 45 CORT SCREW/SELFT  2.7 X 46 CORT SCREW/SELFT  2.7 X 48 CORT SCREW/SELFT  2.7 X 50 CORT SCREW/SELFT  4.0 X 20 CANC SCREW/SELFT",
      "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": "61173335  61173337  61173339  61173340  61173341  61115956  61173344  61173346  61173347  61173349  61173350  61173352  61173353  61173354  61173355  61173356  61173357  61173358  61173359  61173360  61173361  61173362  61173363  61173364  61173365  61173366  61359816",
      "more_code_info": ""
    }
  ]
}