{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Franksville",
      "state": "WI",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "86572",
      "recalling_firm": "Merz North America, Inc.",
      "address_1": "4133 Courtney Rd Ste 10",
      "address_2": "N/A",
      "postal_code": "53126-9127",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "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",
      "recall_number": "Z-0401-2021",
      "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.    Product is packaged in a 1.0cc syringe and packed in a sterile pouch.",
      "product_quantity": "2051 units",
      "reason_for_recall": "The Instructions for Use (IFU) updated 03/02/2020 does not match data listed in the post-approval study.",
      "recall_initiation_date": "20200930",
      "center_classification_date": "20201116",
      "report_date": "20201125",
      "code_info": "Model M0068903000, Lots: 100127846, 100127847, 100128709, 100128710, 100129357, 100129614, and 100129615"
    }
  ]
}