{
  "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": "2026-08-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "191247",
      "product_res_number": "Z-0556-2022",
      "event_date_initiated": "2021-12-13",
      "event_date_created": "2022-02-02",
      "recall_status": "Open, Classified",
      "res_event_number": "89309",
      "product_code": "PBQ",
      "k_numbers": [
        "K160569"
      ],
      "product_description": "The EnPlace is a single use trans-vaginal pelvic floor repair system which enables delivery of a tissue anchor to the ligaments of the vaginal cavity. \nThe anchors are pre-loaded inside the device shaft and are ready for use. \nA thimble is also supplied, as an accessory for the device, to be used as a guide channel for better handling of the EnPlace. \nIntended Use / Indications for Use: The EnPlace system is intended for attaching sutures to ligaments of the pelvic floor.",
      "code_info": "UDI (01)07290017 08201 1 (10) YYMMDDXX (11)YYMMDD (17)YYMMDD, Lot Numbers:  21072510 and 21072512.",
      "firm_fei_number": "3010892271",
      "recalling_firm": "FEMSelect Ltd",
      "address_1": "HaMa'ayan 2 2 hama'ayan",
      "address_2": "First Floor",
      "city": "Modi'in",
      "country": "Israel",
      "reason_for_recall": "Certain lots may not have been packaged wth the Channel Tube Limiter.",
      "root_cause_description": "Process design",
      "action": "On Monday, December 13, 2021, FEMSelect alerted the US distributor both by phone and with a letter sent by email. The formal Recall Notice was sent on December 14, 2021. The recalling firm is requesting the return of the devices.",
      "product_quantity": "141 units",
      "distribution_pattern": "US Nationwide distribution in the state of Georgia.",
      "openfda": {
        "k_number": [
          "K130059",
          "K213783",
          "K260380",
          "K042603",
          "K220420",
          "K230730",
          "K160569",
          "K120831"
        ],
        "device_name": "Fixation, Non-Absorbable Or Absorbable,  For Pelvic Use",
        "medical_specialty_description": "Obstetrics/Gynecology",
        "regulation_number": "884.4530",
        "device_class": "2",
        "registration_number": [
          "3015192261",
          "3024820202",
          "2183744",
          "3004612223",
          "3010892271",
          "2125050",
          "3006621295",
          "3008729892",
          "3004838863"
        ],
        "fei_number": [
          "3015192261",
          "3002807555",
          "3024820202",
          "2183744",
          "3004612223",
          "3010892271",
          "2125050",
          "3006621295",
          "3004838863"
        ]
      }
    }
  ]
}