{
  "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": "216096",
      "product_res_number": "Z-0152-2026",
      "event_date_initiated": "2025-09-09",
      "event_date_posted": "2025-10-14",
      "recall_status": "Open, Classified",
      "res_event_number": "97605",
      "product_code": "LZY",
      "k_numbers": [
        "K954768"
      ],
      "product_description": "BioPro Endo Head (Ceramic)\n\nProduct ID/Description\n13006\tENDO MODULAR CERAMIC SH 38\n13012\tENDO MODULAR CERAMIC SH 51\n13013\tENDO MODULAR CERAMIC MD 38\n13019\tENDO MODULAR CERAMIC MD 51\n13007\tENDO MODULAR CERAMIC SH 41\n13008\tENDO MODULAR CERAMIC SH 43\n13009\tENDO MODULAR CERAMIC SH 45\n13010\tENDO MODULAR CERAMIC SH 47\n13011\tENDO MODULAR CERAMIC SH 49\n13014\tENDO MODULAR CERAMIC MD 41\n13015\tENDO MODULAR CERAMIC MD 43\n13016\tENDO MODULAR CERAMIC MD 45\n13017\tENDO MODULAR CERAMIC MD 47\n13018\tENDO MODULAR CERAMIC MD 49\n14823\tENDO MODULAR CERAMIC SH 53\n14824\tENDO MODULAR CERAMIC MD 53\n14825\tENDO MODULAR CERAMIC SH 55\n14826\tENDO MODULAR CERAMIC MD 55\n17295\tENDO MODULAR CERAMIC SH 36\n17296\tENDO MODULAR CERAMIC MD 36",
      "code_info": "Product ID/UDI-DI\n\n13006\tM20913006\n13012\tM20913012\n13013\tM20913013\n13019\tM20913019\n13007\tM20913007\n13008\tM20913008\n13009\tM20913009\n13010\tM20913010\n13011\tM20913011\n13014\tM20913014\n13015\tM20913015\n13016\tM20913016\n13017\tM20913017\n13018\tM20913018\n14823\tM20914823\n14824\tM20914824\n14825\tM20914825\n14826\tM20914826\n17295\tM20917295\n17296\tM20917296\n\nAll lots, all serial numbers",
      "firm_fei_number": "1832656",
      "recalling_firm": "BioPro, Inc.",
      "address_1": "2929 Lapeer Rd",
      "city": "Port Huron",
      "state": "MI",
      "postal_code": "48060-2558",
      "additional_info_contact": "Mr. Patrick Pringle\n810-982-7777",
      "reason_for_recall": "Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.",
      "root_cause_description": "Package design/selection",
      "action": "Consignees were notified on September 9, 2025, via phone, followed by formal letters with instructions for returning the inventory to BioPro.",
      "product_quantity": "147 total",
      "distribution_pattern": "US Domestic distribution to Texas and Michigan.",
      "openfda": {
        "k_number": [
          "K892059",
          "K903084",
          "K915548",
          "K111145",
          "K231448",
          "K896580",
          "K915528",
          "K974442"
        ],
        "registration_number": [
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        "fei_number": [
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          "3002808293",
          "3002808269",
          "3008868758",
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          "1825034",
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        ],
        "device_name": "Prosthesis, Hip, Hemi-, Femoral, Metal Ball",
        "medical_specialty_description": "Orthopedic",
        "regulation_number": "888.3360",
        "device_class": "2"
      }
    }
  ]
}