{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Akron",
      "state": "OH",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "97676",
      "recalling_firm": "Theken Companies LLC",
      "address_1": "1800 Triplett Blvd",
      "address_2": "",
      "postal_code": "44306-3311",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "US Nationwide distribution in the states of NJ, PA, and TX.",
      "recall_number": "Z-0227-2026",
      "product_description": "iNSitu Bipolar Hip System, Bipolar head implant    Part ID\tDescription  10-22-0038\tBipolar Head Assembly, Size 38mm  10-22-0040\tBipolar Head Assembly, Size 40mm  10-22-0042\tBipolar Head Assembly, Size 42mm  10-22-0044\tBipolar Head Assembly, Size 44mm  10-22-0046\tBipolar Head Assembly, Size 46mm  10-22-0048\tBipolar Head Assembly, Size 48mm  10-22-0050\tBipolar Head Assembly, Size 50mm  10-22-0052\tBipolar Head Assembly, Size 52mm  10-22-0054\tBipolar Head Assembly, Size 54mm  10-22-0056\tBipolar Head Assembly, Size 56mm  10-22-0058\tBipolar Head Assembly, Size 58mm  10-22-0060\tBipolar Head Assembly, Size 60mm",
      "product_quantity": "409",
      "reason_for_recall": "Downstream recall for RES 97605, BioPro femoral components. Product failed transit testing. Impacted product may have potential issues with sterile barrier.",
      "recall_initiation_date": "20250911",
      "center_classification_date": "20251021",
      "report_date": "20251029",
      "code_info": "10-22-0038  UDI-DI 00816127029431  Lots 2036, 2036-RP, 3495, 3495-1;  10-22-0040  UDI-DI 00816127029448  Lots 2037, 2037-RP, 3491, 3491-1;  10-22-0042  UDI-DI 00816127029455  Lot 2038-RP;  10-22-0044  UDI-DI 00816127029462   Lots 2039-RP, 3496-1;  10-22-0046  UDI-DI 00816127029479  Lots 2040, 2040-RP, 3492, 3492-1;  10-22-0048  UDI-DI 00816127029486   Lot 2041-RP;  10-22-0050  UDI-DI 00816127029493  Lots 2042, 2042-RP;  10-22-0052  UDI-DI 00816127029509  Lots 2043, 2043-RP;  10-22-0054  UDI-DI 00816127029516  Lots 2044, 2044-RP;  10-22-0056  UDI-DI 00816127029523  Lots 2045, 2045-RP;  10-22-0058  UDI-DI 00816127029530  Lots 2046, 2046-RP, 3493;  10-22-0060  UDI-DI 00816127029547  Lots 2047, 2047-RP, 3494  All lots/serial numbers",
      "more_code_info": ""
    }
  ]
}