{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "104960",
      "product_res_number": "Z-0440-2012",
      "event_date_initiated": "2011-09-21",
      "event_date_posted": "2012-01-11",
      "recall_status": "Terminated",
      "event_date_terminated": "2013-09-27",
      "res_event_number": "60138",
      "product_code": "NRA",
      "product_description": "\"***BUECHEL-PAPPAS MODULAR TIBIAL BEARING ***MATERIAL UHMWPe***STERILE EO***ENDOTEC***Endotec, Inc. 20 Valley Street South Orange NJ, 07079 USA Tel (973)762-6100***Wright Cremascoli Ortho Ltd. Unit 17 Goldworth Park Trading Estate Woking, Surrey GU213BA England Tel (0)1483-721404***\"     \n\nCat #: 04-33-1002 Modular Tibial Bearing 2 X 0 \nCat #: 04-33-1003 Modular Tibial Bearing 3 X 0 \nCat #: 04-33-1004 Modular Tibial Bearing 4 X 0 \nCat #: 04-33-1005 Modular Tibial Bearing 5 X 0 \nCat #: 04-33-1006 Modular Tibial Bearing 6 X 0.\n\nTricompartmental Knee Replacement",
      "code_info": "LOT #'s:   04331002ANN286,  04331003ANN286,  04331004ANN286,  04331005ANN286,  04331006ANN286",
      "firm_fei_number": "3004553437",
      "recalling_firm": "Endotec, Inc.",
      "address_1": "300 Sunport Ln Ste 500 300 Sunport Ln",
      "address_2": "Ste 500",
      "city": "Orlando",
      "state": "FL",
      "postal_code": "32809-8123",
      "additional_info_contact": "Faranak Gomarooni\n800-323-9890",
      "reason_for_recall": "On 09/21/2011 Endotec, Orlando, FL initiated a recall for the Beuchel-Pappas Mobile Bearing Knee System (BP Knee).  The BP Mobile Bearing Knee System consists of unapproved mobile (rotating) bearing tibial and patellar components.",
      "root_cause_description": "PMA",
      "action": "Endotec sent an \"URGENT: MEDICAL DEVICE RECALL\" letter dated September 21, 2011 to all affected customers.  The letter described the product, problem, and actions to be taken by the customers.  The letter instructs customers to examine and quarantine product subject to the recall. Additionally, a Response Form was included with the letter for customers to complete and return to the firm.  Call 862-703-6730 for questions regarding this recall.",
      "product_quantity": "39",
      "distribution_pattern": "USA (nationwide) including the states of AZ, CA, CT, FL, NE, NJ, OH, and OK.",
      "openfda": {
        "pma_number": [
          "P910016",
          "P010014"
        ],
        "registration_number": [
          "1721676",
          "1450662",
          "3002806535",
          "1818910",
          "3006946279",
          "1822565",
          "3007923096",
          "3014315560",
          "3012392319",
          "3002807310",
          "1825034",
          "3013055499",
          "3004748528",
          "3006801265",
          "3007963827"
        ],
        "fei_number": [
          "1000220733",
          "1721676",
          "1450662",
          "3002806535",
          "1818910",
          "3006946279",
          "3007923096",
          "3014315560",
          "3012392319",
          "3002807310",
          "1825034",
          "3013055499",
          "3004748528",
          "3006801265",
          "3007963827"
        ],
        "device_name": "Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}