{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Buxtehude",
      "state": "",
      "country": "Germany",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "88047",
      "recalling_firm": "IMPLANTCAST GMBH",
      "address_1": "Luneburger Schanze 26",
      "address_2": "",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "U.S. Nationwide distribution in the states of FL and TX.",
      "recall_number": "Z-2050-2021",
      "product_description": "EcoFit cup cementless:  Model(Catalog Number)/Description: 02200046 /EcoFit cup cementless  46mm dia incl. central hole cover; 02200048 /EcoFit cup cementless  48mm dia incl. central hole cover; 02200050 /EcoFit cup cementless  50mm dia incl. central hole cover; 02200052 /EcoFit cup cementless  52mm dia incl. central hole cover; 02200054 /EcoFit cup cementless  54mm dia incl. central hole cover; 02200056 /EcoFit cup cementless  56mm dia incl. central hole cover; 02200058 /EcoFit cup cementless  58mm dia incl. central hole cover; 02200060 /EcoFit cup cementless  60mm dia incl. central hole cover; 02200062 /EcoFit cup cementless  62mm dia incl. central hole cover; 02200064 /EcoFit cup cementless  64mm dia incl. central hole cover; 02200066 /EcoFit cup cementless  66mm dia incl. central hole cover; 02200068 /EcoFit cup cementless  68mm dia incl. central hole cover;",
      "product_quantity": "41 units (U.S.)",
      "reason_for_recall": "A risk exists during impacting of the acetabular cup into the bone the plugs may come loose from the cup, which could lead to operation duration extension or revision operation. A warning note is being added to instructions for use and surgical technique alerting users that the quality of bone in the patient (such as osteosclerosis) is an attributable factor.",
      "recall_initiation_date": "20210510",
      "center_classification_date": "20210709",
      "termination_date": "20221118",
      "report_date": "20210721",
      "code_info": "Instructions for Use Reference Number: ECOCUOPU and Surgical Technique Reference Number:09300038US    Model(Catalog Number)/Description:  02200046 /EcoFit¿ cup cementless ¿ 46mm incl. central hole cover;  UDI: 04048844005368  Lot Numbers:  1736252001;  1736252003;  1736252004;  1736252006;  1736252007;  1736252008;  1736252010;  18481C0027;  18481C0010;  18481C0004;  18481C0013;  18481C0005;  18481C0024;    02200048 /EcoFit¿ cup cementless ¿ 48mm incl. central hole cover;  UDI: 04048844005375  Lot Numbers:  17420NM001  17420NM002  17420NM003  17420NM005  17420NM007  17420NM010  17420NM011  17420NM012  17420NM013  17420NM014  17420NM015  17420NM016  17420NM018  17420NM019  17420NM020  17420NM021  17420NM022  17420NM023  17420NM025   17420NM026    02200050 /EcoFit¿ cup cementless ¿ 50mm incl. central hole cover;  UDI: 04048844005382  Lot Numbers:  174111N008  174111N012  174111N018  190414M002  190414M003  190414M004  190414M012  190414N016  174111N002  174111N005  174111N006  174111N013  174111N022  174111N023  174111N026  190625J027  190625J026  190625J028  190625J009  190625J012  190625J014  190625J021  190625J020  190625J001  190625J017  190625J006  190625J002  190625J004  190625J018    02200052 /EcoFit¿ cup cementless ¿ 52mm incl. central hole cover;  UDI: 04048844005399  Lot Numbers:  1736253002  1736253005  1736253007  1736253008  1736253015  1736253016  1736253017  1736253021  1736253004  1736253006  1736253014  1736253019  1736253020  1736253022  1736253023  190909E021  190909E005  190909E014  190909E004  190909E017  190909E025  190909E002  190909E018  190909E023  190909E006  190909E009  190909E001    02200054 /EcoFit¿ cup cementless ¿ 54mm incl. central hole cover;  UDI: 04048844005405  Lot Numbers:  1748194005  1748194007  1748194008  1748194011  1748194013  1748194016  1748194022  1748194023  1748194025  1748194026  1748194001  1748194003  1748194006  1748194012  1748194017  1748194018  1748194020  1748194028  1849208014  1849208004  1849208012  185019I006   1849208001  1849208006  185019I004   1849208009    02200056 /EcoFit¿ cup cementless ¿ 56mm incl. central hole cover;  UDI: 04048844005412  Lot Numbers:  174817C002  174817C004  174817C009  174817C010  174817C011  174817C013  17481M2002  17481M2007  174817C001  174817C003  174817C005  174817C007  174817C008  174817C012  17481L7001  17481M2005  17481M2008  17481M2011  19061JB024  19061JB008  19061JB005  19061JB003  19061JB020  19061JB006  19061JB023  19061JB002  19061JB019      02200058 /EcoFit¿ cup cementless ¿ 58mm incl. central hole cover;  UDI: 04048844005429  Lot Numbers:  1738104009  173810D001  173810D002  173810D003  173810D004  173810D006  173810D007  173810D008  173810D009  173810D012  173810D014  173810D015  173810D005  173810D010  173810D011  173810D013    02200060 /EcoFit¿ cup cementless ¿ 60mm incl. central hole cover;  UDI: 04048844005436  Lot Numbers:  1738116001  1738116002  1738116003  1738116004  1738116005  1738116006  1738116008  1738116018  1738116019  1738116021  1738116023  1738116025  1738116007  1738116010  1738116013    02200062 /EcoFit¿ cup cementless ¿ 62mm incl. central hole cover;  UDI: 04048844005443  Lot Numbers:  1741126001  1741126003  1741126004  1741126005  1741126010  1741126011  1741126012  1741126015  1741126017  1741126020  15190KC048  1741126013  1741126016  1741126006    02200064 /EcoFit¿ cup cementless ¿ 64mm incl. central hole cover;  UDI:04048844005450  Lot Numbers:  1741104001  1741104002  1741104003  1741104005  1741104007  1741104018  1741104020  1741104021  1741104022  1741104010  1741104004  1741104019    02200066 /EcoFit¿ cup cementless ¿ 66mm incl. central hole cover;  UDI: 04048844005467  Lot Numbers:  174110E002  174110E004  174110E007  174110E008  174110E009  174110E011  174110E013  174110E003   174110E012  174110E010  174110E006  174110E005    02200068 /EcoFit¿ cup cementless ¿ 68mm incl. central hole cover;  UDI: 04048844005474  Lot Numbers:  17410JK001  17410JK002  17410JK003   17410JK004  17410KM001  17410KM003  17410KM004  17410KM005  17410KM006  17410KM007  17410KM009  17410KM010  17410KM011  1416I6G089  1439O4K008",
      "more_code_info": ""
    }
  ]
}