{
  "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-1040-2014",
      "product_description": "PERI SCR. 3.5MM X 10MM     PERI SCR. 3.5MM X 12MM     PERI SCR. 3.5MM X 14MM     PERI SCR 3.5MM X 44MM STE  PERI SCR. 3.5MM X 65MM     PERI. SCR 4.0MM X24MM      PERI. SCR 4.0MM X40MM      PERI SCR. 4.0MMX14MM FULL  PERI SCR. 4.0MMX32MM FULL  PERI SCR. 4.0MMX38MM FULL  3.5MM CORT SCR X 10MM      3.5MM CORT SCR X 12MM      3.5MM CORT SCR X 14MM      3.5MM CORT SCR X 16MM      3.5MM CORT SCR X 18MM      3.5MM CORT SCR X 20MM      3.5MM CORT SCR X 22MM      3.5MM CORT SCR X 24MM      3.5MM CORT SCR X 26MM      3.5MM CORT SCR X 28MM      3.5MM CORT SCR X 30MM      3.5MM CORT SCR X 32MM      3.5MM CORT SCR X 34MM      3.5MM CORT SCR X 36MM      3.5MM CORT SCR X 38MM      3.5MM CORT SCR X 40MM      3.5MM CORT SCR X 42MM      3.5MM CORT SCR X 44MM      3.5MM CORT SCR X 46MM      3.5MM CORT SCR X 48MM      3.5MM CORT SCR X 50MM      3.5MM CORT SCR X 52MM      3.5MM CORT SCR X 54MM      3.5MM CORT SCR X 56MM      3.5MM CORT SCR X 58MM      3.5MM CORT SCR X 60MM      3.5MM CORT SCR X 65MM      3.5MM CORT SCR X 70MM      3.5MM CORT SCR X 75MM      3.5MM CORT SCR X 80MM      3.5MM CORT SCR X 85MM      3.5MM CORT SCR X 90MM      3.5MM CORT SCR X 100MM     3.5MM CORT SCR X 105MM     3.5MM CORT SCR X 110MM     CANC SCR 4.0MM X 10MM      CANC SCR 4.0MM X 10MM FUL  CANC SCR 4.0MM X 12MM      CANC SCR 4.0MM X 12MM FUL  CANC SCR 4.0MM X 14MM      CANC SCR 4.0MM X 14MM FUL  CANC SCR 4.0MM X 16MM      CANC SCR 4.0MM X 16MM FUL  CANC SCR 4.0MM X 18MM      CANC SCR 4.0MM X 18MM FUL  CANC SCR 4.0MM X 20MM      CANC SCR 4.0MM X 20MM FUL  CANC SCR 4.0MM X 22MM      CANC SCR 4.0MM X 22MM FUL  CANC SCR 4.0MM X 24MM      CANC SCR 4.0MM X 24MM FUL  CANC SCR 4.0MM X 26MM      CANC SCR 4.0MM X 26MM FUL  CANC SCR 4.0MM X 28MM      CANC SCR 4.0MM X 28MM FUL  CANC SCR 4.0MM X 30MM      CANC SCR 4.0MM X 30MM FUL  CANC SCR 4.0MM X 32MM      CANC SCR 4.0MM X 32MM FUL  CANC SCR 4.0MM X 34MM      CANC SCR 4.0MM X 34MM FUL  CANC SCR 4.0MM X 36MM      CANC SCR 4.0MM X 36MM FUL  CANC SCR 4.0MM X 38MM      CANC SCR 4.0MM X 38MM FUL  CANC SCR 4.0MM X 40MM      CANC SCR 4.0MM X 40MM FUL",
      "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": "61337161  61251498  61251499  61220432  61553288  61966252  61966257  60856802  60871924  60871946  60837236  61168818  61168821  61251340  61168823  61251341  61168825  61216588  61247526  61168827  61216589  61247527  61168829  61216590  61247528  61168830  61216591  61247529  61168831  61247530  61168833  61216593  61247531  61168835  61247532  61168837  61216596  61247533  61168839  61168841  61168842  61168843  61168845  61247536  61168847  61223705  61168849  61168850  61168852  61168854  61168856  61168858  61168859  61168860  61168861  61168862  61567437  61411579  61678383  61678382  61835910  61835909  61214649  61216599  61214650  61216602  61251346  61216605  61591005  61190532  61190535  61740546  61190538  61190539  61401997  61190540  61190543  61560426  61823977  61190544  61190546  61740547  61190547  61190549  61740548  61190551  61190552  61560430  61190554  61190555  61560431  61190618  61190619  61740550  61190620  61190627  61560427  61190628  61190629  61401998  61190630  61190632  61740551  61190633  61190634  61740552  61190635  61190636  61740553  61190638  61190639  61190640  61190641  61190642  61740554  61190643",
      "more_code_info": ""
    }
  ]
}