{
  "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-1023-2014",
      "product_description": "MODULAR CUP NEUTRAL LINER  MODULAR CUP 10 DEGREE LIN  MODULAR CUP 20 DEGREE LIN  MODULAR CUP 7MM OFFSET LI",
      "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": "61547919  61954158  61241463  61821673  62188365  61564304  60919205  61666604  60928241  62086340  62296755  60611445  60841757  60863748  61187640  61224727  61261826  62062929  62173370  60550153  60588810  60828784  61018862  61110916  61159634  62296754  60576173  61209715  61564309  60575226  60595581  60623653  60749578  62316407  60611447  61255394  61364450  61382532  60611244  60817929  60863723  60563186  62268497  61547941  62137191  61892712  61901662  60668061  61584777  61059234  61403759  60497031  61303608  61875716  62087621  62138394  61906179  61919744  61853252  60945780  61403762  61868301  62123088  62330868  61552276  60973584  61159666  61209871  61491267  61731038  61906430  62154608  60806194  60940002  61092880  62304925  61598585  61698771  61712665  61902214  62148657  60612251  60658071  60980492  61072064  61160052  61261860  61642713  61722445  62296659  60715034  61018915  61036921  61136634  61179946  61377132  61504792  61564330  61598593  61652828  61662223  61746897  61885964  61902215  62062927  62166311  62166312  62167440  60664534  60611465  61121730  61491274  61542625  62170707  62296657  62304924  61138050  61392960  61509276  61591304  61662225  61751908  61875723  61885967  61902216  62113239  62183216  62308937  62322488  60715040  60715041  62134061  62292055  61407093  61509275  61564339  61598601  61751904  61928945  62183217  62292053  62330877  61575699  61403906  60699177  61591302  62127617  62301528  60545115  61504789  61698789  61863756  62109142  62296661  61261880  61403757  62123083  62296662  60595588  61407096  61633829  61788072  62296663  60593824  60841777  61424558  62268509  61509269  61580668  61631807  62330880  61234865  61286973  61521041  62049367  61241564  61542576  61751903  62147386  61478541  60588818  62118728  61403756  61598607  62044858  62329122  61547934  62147387  61478392  61575705  61788071  62329128  61712669  61005950  60945793  60595589  61765738  61036924  61668359  61478415  62330884  61110936  61675948  61138057  62301533  60717011  60611470  60656941  60863743  62330885  60715052  61287001  61751907  60600334  62296665  62327789  61651457  62292056  60862307  62077408  62180255  62296658  62000454  62127618  61651453  61547925  60612264  62123082  61224783  60595598  61652830  61765723  61005427  60584587  61547937  60643575  60885073  61623060  60885074  61641918  61241575  61261913  61643326  60642954  61461428  61457271  60676424  60767532  61436014",
      "more_code_info": ""
    }
  ]
}