{
  "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": "85729",
      "product_res_number": "Z-0171-2010",
      "event_date_initiated": "2009-10-06",
      "event_date_posted": "2009-11-10",
      "recall_status": "Terminated",
      "event_date_terminated": "2011-12-12",
      "res_event_number": "53531",
      "product_code": "FHW",
      "pma_numbers": [
        "P000006"
      ],
      "product_description": "Coloplast Titan OTR Inflatable Penile Prosthesis,18cm scrotal Bioflex cylinder set w/OTR Pump, P/N QSR9181400.  Sterile EO.  Manufacturer:  Coloplast A/S, 3050 Denmark.  Distributed by:  Coloplast Corp., Minneapolis, MN  55411 USA.\n\nIndicated for male patients suffering from erectile dysfunction who are considered to be candidates for implantation of a penile prosthesis.",
      "code_info": "Lot 1919244.",
      "firm_fei_number": "2125050",
      "recalling_firm": "Coloplast Manufacturing US, LLC",
      "address_1": "1601 W River Rd",
      "city": "Minneapolis",
      "state": "MN",
      "postal_code": "55411-3430",
      "additional_info_contact": "612-302-4992",
      "reason_for_recall": "Coloplast determined that a portion of Titan OTR pumps were manufactured using a process that where validation activities were not completed.  The Titan OTR pumps were made to our standard product specifications and have passed all in-process testing to ensure mechanical reliability of these pumps.  Coloplast is not recommending product explant because there are no identified risks since the prod",
      "root_cause_description": "Process control",
      "action": "Coloplast issued a customer notification letter dated October 2009 describing the affected product.\n\nFor further information, contact Coloplast at 1-800-533-0464.",
      "product_quantity": "3",
      "distribution_pattern": "Nationwide Distribution -- FL, GA, NC.",
      "openfda": {
        "pma_number": [
          "N970012",
          "P000006"
        ],
        "registration_number": [
          "2124215",
          "2125050",
          "3005099803",
          "3002907620",
          "2183744",
          "1423662",
          "2246552"
        ],
        "fei_number": [
          "2124215",
          "2125050",
          "3005099803",
          "3002907620",
          "3000215273",
          "2183744",
          "2246552"
        ],
        "device_name": "Device, Impotence, Mechanical/Hydraulic",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.3350",
        "device_class": "3"
      }
    }
  ]
}