{
  "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-1006-2014",
      "product_description": "VERSA-FX KEYLESS 90D X 8 and X 11, VERSA-FX KEYLESS 95D X 8, X 11, and X 14, VERSA-FX KEYLESS 140D X 4 and X 5, VERSA-FX KEYLESS 135D X 4 and X 5, VERSA-FX SHORT TUBE, 130D, 135D and 140D, VERSA-FX STANDARD TUBE, 1 and VERSA-FX SPRCNDLR TUBE, 9    Item codes starting with 001980, 001981, 0011990 and 0011991",
      "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": "60053473  60528659  60807849  60855076  365855  60807850  60855077  365856  60143351  60384033  60403721  60452546  60543211  60632720  60807851  368913  369123  60219007  60740783  60993433  365857  369559  371074  60539739  60807852  365859  60098398  60119108  60241936  60625494  60082810  60625506  365860  365861  60222477  60109715  60187232  366023  60161891  60116180  60175536  365749  60082811  60109716  60123966  60175537  60231394  60097992  60119110  60123967  60143352  60154511  60165702  60175538  60231395  365740  366424  60109717  60112053  60112054  60116181  60116182  60119111  60119112  60129316  60129317  60154512  60154513  60165703  60175539  60187233  60187234  60206858  60206859  60241934  60161892  365739  60109718  365738  60123968  366024  366025  60136407  365752  365751  60123969  60154514  60082812  60109719  365753  365743  60163222",
      "more_code_info": ""
    }
  ]
}