{
  "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": "2026-04-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Raynham",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "80406",
      "recalling_firm": "OMNIlife science Inc.",
      "address_1": "480 Paramount Dr",
      "address_2": "N/A",
      "postal_code": "02767-1085",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Telephone",
      "distribution_pattern": "US Nationwide Distribution - in the states of AZ, CA, CO, IL, FL & MA",
      "recall_number": "Z-2540-2018",
      "product_description": "OMNI Hip System, ApeX-LNK Acetabular Inserts 0 degree, 4+mm offset, Product Codes: H6-14436, H6-13928 & H6-14836    Product Usage:  The Apex Hip System is intended for primary or revision total hip replacement. The femoral hip stems and acetabular cups are intended for uncemented fixation and single use implantation. The Apex Acetabular Cup liners, standard and ApeX-LNK Poly, are intended for use with the Apex Modular Acetabular Cup, in combination with the Apex Modular, Apex K2, Apex K2 mid length or Apex K1 Hip in total hip replacement procedures. The acetabular cup inserts are intended to articulate with a metal (cobalt chromium) or ceramic (alumina) femoral head. These prostheses may be used for the following conditions, as appropriate:   Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis   Rheumatoid arthritis   Correction of functional deformity   Congenital dislocation   Revision procedures where other treatments or devices have failed",
      "product_quantity": "16 units",
      "reason_for_recall": "The Internal packaging, the pouch and patient labels are improperly labeled.",
      "recall_initiation_date": "20180518",
      "center_classification_date": "20180725",
      "termination_date": "20190128",
      "report_date": "20180801",
      "code_info": "Lot Numbers - 29147, 29148 & 29778"
    }
  ]
}