{
  "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": "2026-09-12",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "218134",
      "product_res_number": "Z-1220-2026",
      "event_date_initiated": "2025-12-31",
      "event_date_posted": "2026-01-29",
      "recall_status": "Open, Classified",
      "res_event_number": "98280",
      "product_code": "QNI",
      "k_numbers": [
        "K243578"
      ],
      "product_description": "BEAR Implant. Model Number: 1000.",
      "code_info": "Model Number: 1000. UDI Number: (01)00860002987804(17)260228(10)7011098. Lot Number: 7011098. Expiration Date: 02/28/2026.",
      "firm_fei_number": "3020652309",
      "recalling_firm": "Miach Orthopaedics",
      "address_1": "69 Milk St Ste 100 69 Milk St",
      "address_2": "Ste 100",
      "city": "Westborough",
      "state": "MA",
      "postal_code": "01581-1224",
      "additional_info_contact": "Matthew Snodgrass\n800-590-6995",
      "reason_for_recall": "Incorrect expiration date on label that extends beyond the product's documented/approved shelf life.  With an incorrect expiration date, the UDI will also be incorrect.",
      "root_cause_description": "Process control",
      "action": "Notification to Sales Representatives and consignees began on about 12/31/2025 via email and letter titled URGENT MEDICAL DEVICE RECALL NOTIFICATION.  Consignees were instructed to identify and quarantine all unused inventory of the affected lot, discontinue distribution of the affected lot, return all unused affected product, and complete and return the provided Recall Acknowledgement Form.  Additionally, consignees were requested to notify customers if the affected lot was further distributed.",
      "product_quantity": "284 units",
      "distribution_pattern": "US Nationwide distribution in the states of AK, CA, CO, CT, FL, GA, IL, MA, MD, ME, MI, MN, MO, NC, NJ, NY, OH, OR, TX, VA, WA, WI.",
      "openfda": {
        "k_number": [
          "K243578",
          "DEN200035",
          "K251214"
        ],
        "registration_number": [
          "3013820501",
          "2530154",
          "3020652309"
        ],
        "fei_number": [
          "3013820501",
          "1000307073",
          "3020652309"
        ],
        "device_name": "Resorbable Implant For Anterior Cruciate Ligament (Acl) Repair",
        "medical_specialty_description": "Orthopedic",
        "regulation_number": "888.3044",
        "device_class": "2"
      }
    }
  ]
}