{
  "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": "184068",
      "product_res_number": "Z-0401-2021",
      "event_date_initiated": "2020-09-30",
      "event_date_created": "2020-11-16",
      "recall_status": "Open, Classified",
      "res_event_number": "86572",
      "product_code": "LNM",
      "pma_numbers": [
        "P040047"
      ],
      "product_description": "COAPTITE Injectable Implant, injectable, sterile, non-pyrogenic implant composed of spherical particles (75-125 microns in diameter of calcium hydroxylapatite (CaHA), suspended in aqueous based gel carrier.  Gel carrier is composed of sodium carboxymethylcellulose, sterile water for injection, and glycerin.\n\nProduct is packaged in a 1.0cc syringe and packed in a sterile pouch.",
      "code_info": "Model M0068903000, Lots: 100127846, 100127847, 100128709, 100128710, 100129357, 100129614, and 100129615",
      "firm_fei_number": "3003407669",
      "recalling_firm": "Merz North America, Inc.",
      "address_1": "4133 Courtney Rd Ste 10 4133 Courtney Rd",
      "address_2": "Ste 10",
      "city": "Franksville",
      "state": "WI",
      "postal_code": "53126-9127",
      "additional_info_contact": "Boston Scientific Call Center\n866-868-4004",
      "reason_for_recall": "The Instructions for Use (IFU) updated 03/02/2020 does not match data listed in the post-approval study.",
      "root_cause_description": "Labeling design",
      "action": "Merz NA, in cooperation with Boston Scientific Corporation (BSC) have prepared field action communications including a Medical Device Field Notification Letter and Urgent Medical Device Field Notification Response Form.  These letters will be sent via FedEx with delivery confirmation.\n\nThe units at consignees will not be returned but will be furnished with an updated, revision-controlled IFU.",
      "product_quantity": "2051 units",
      "distribution_pattern": "US only distribution - AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV",
      "openfda": {
        "device_name": "Agent, Bulking, Injectable For Gastro-Urology Use",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3",
        "pma_number": [
          "P030030",
          "P980053",
          "P170023",
          "P020006",
          "P040050",
          "P000029",
          "P900030",
          "P100014",
          "P040047"
        ],
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        "fei_number": [
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