{
  "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": "2026-09-17",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "216478",
      "product_res_number": "Z-0479-2026",
      "event_date_initiated": "2023-02-02",
      "event_date_posted": "2025-11-07",
      "recall_status": "Open, Classified",
      "res_event_number": "97742",
      "product_code": "QNI",
      "k_numbers": [
        "K243578"
      ],
      "product_description": "BEAR Implant (Bridge-Enhanced ACL Restoration);\nModel/Catalog: 1000;",
      "code_info": "Model/Catalog: 1000;\nUDI-DI: 00860002987804; \nLot number: 7008409;",
      "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": "Gregory DeVenne\n800-590-6995",
      "reason_for_recall": "The field action was initiated in February of 2023 and was limited to the affected lot from sales force trunk stock only.",
      "root_cause_description": "Under Investigation by firm",
      "action": "On January 30, 2023 RE: BEAR Implant Hydration memo emails were sent to sales staff. If you observe an implant that hydrates too quickly (e.g., less than 30 seconds) and appears that it may not remain intact upon insertion into the knee, do not attempt to implant the device. We would recommend you always have a backup device available to address such circumstances.\nWe plan to revise the Tips and Pearls document, ML-1027, to provide further instructions/details on how to properly hydrate the BEAR device. In the meantime, one way to avoid shortened hydration time is to consider hydrating the  dense side  of the implant first and continue toward the  porous side .\nTo date, all reports of this observation have involved Lot # 7008409. As a precaution and to ensure customer satisfaction, we are asking that you return all devices from this lot that are currently in your  trunk stock  (in your possession). Chris Brown will work with you to coordinate returns as well as replacing these trunk stock devices.\nPlease contact me (mohara@miachortho.com) or Arjun (aishwar@miachortho.com) if you have questions.",
      "product_quantity": "167 units",
      "distribution_pattern": "US Nationwide distribution.",
      "openfda": {
        "k_number": [
          "K243578",
          "DEN200035",
          "K251214"
        ],
        "device_name": "Resorbable Implant For Anterior Cruciate Ligament (Acl) Repair",
        "medical_specialty_description": "Orthopedic",
        "regulation_number": "888.3044",
        "device_class": "2",
        "registration_number": [
          "2530154",
          "3013820501",
          "3020652309"
        ],
        "fei_number": [
          "1000307073",
          "3013820501",
          "3020652309"
        ]
      }
    }
  ]
}