{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "43348",
      "product_res_number": "Z-0337-06",
      "event_date_initiated": "2005-12-14",
      "event_date_posted": "2005-12-31",
      "recall_status": "Terminated",
      "event_date_terminated": "2007-01-29",
      "res_event_number": "34256",
      "product_code": "FWM",
      "pma_numbers": [
        "P990074"
      ],
      "product_description": "McGhan Style 163-360cc Saline-Filled BIOCELL textured Breast Implants, Catalogue Number :163-360",
      "code_info": "Lot#1121514, Serial# 11567927 & 11567935",
      "firm_fei_number": "2024601",
      "recalling_firm": "Inamed Corp",
      "address_1": "71 S Los Carneros Rd",
      "city": "Goleta",
      "state": "CA",
      "postal_code": "93117-5506",
      "additional_info_contact": "Patrick J. Crotteau\n800-624-4261 Ext. 4802",
      "reason_for_recall": "Two lots of products were mislabeled; a lot of twenty Style 468 Breast Implants and a lot of twenty Style 163 Breast Implants. In error, the labels for these two lots were switched during packaging. As a result, a total of 40 devices were mislabeled.",
      "root_cause_description": "Other",
      "action": "On Wednesday, 14-December-2005, Inamed began calling affected customers to notify them of the voluntary recall.\nAt the end of business on Wednesday, 14-December-2005, Inamed distributed Recall Notification Letters via Federal Express overnight mail directly to affected customers.",
      "product_quantity": "2",
      "distribution_pattern": "Nationwide",
      "openfda": {
        "pma_number": [
          "P990074",
          "P990075",
          "P120011"
        ],
        "registration_number": [
          "1645337",
          "1649518",
          "3010531069",
          "2011068",
          "3011310987",
          "3022978896",
          "9617229",
          "3005423519"
        ],
        "fei_number": [
          "1000118360",
          "3001236277",
          "3010531069",
          "2011068",
          "3006165545",
          "3006108784",
          "3011310987",
          "3022978896"
        ],
        "device_name": "Prosthesis, Breast, Inflatable, Internal, Saline",
        "medical_specialty_description": "General, Plastic Surgery",
        "regulation_number": "878.3530",
        "device_class": "3"
      }
    }
  ]
}