{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Warsaw",
      "state": "IN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "86382",
      "recalling_firm": "Biomet, Inc.",
      "address_1": "56 E Bell Dr",
      "address_2": "N/A",
      "postal_code": "46582-6989",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Devices were distributed nationwide throughout the United States and to locations OUS. There has been one unit returned prior to the recall and approximately 14 units that have been previously implanted, leaving 33 units in the field subject to removal.",
      "recall_number": "Z-0097-2021",
      "product_description": "(1) RingLoc Bi-Polar Hip System Acetabular Cup ArCom:   Acetabular Bi-Polar Cup, E1 Antioxidant Infused, 28 MM, 41 MM:   Item No. 110010458; Lot No. 710930; UDI No. (01) 00880304568747 (17) 230614 (10) 710930    (2) RingLoc Hip system Acetabular Bi-Polar Cup:   Acetabular Cup, ArCom, 41 MM OD,  28 MM ID:  Item No. 11-165206, Lot No. 649750; UDI No. (01) 00880304001923 (17) 230614 (10) 649750    (3) RingLoc Bi-Polar Hip System Acetabular Cup ArCom:  Acetabular Cup, ArCom, 52 MM OD, 28 MM ID:   Item No. 11-165228; Lot No. 433290; UDI No. (01) 00880304001930 (17) 230612 (10) 433290",
      "product_quantity": "48 devices",
      "reason_for_recall": "Zimmer Biomet is conducting a medical device recall for three lots of the RingLoc Bi-Polar Hip system Acetabular Cup. The affected lots were gamma sterilized twice. Sufficient data does not exist to support the functionality, shelf life, or package integrity for more than one-time sterilization.",
      "recall_initiation_date": "20200903",
      "center_classification_date": "20201009",
      "termination_date": "20221220",
      "report_date": "20201021",
      "code_info": "(1) RingLoc Bi-Polar Hip System Acetabular Cup ArCom:   Acetabular Bi-Polar Cup, E1 Antioxidant Infused, 28 MM, 41 MM:   Item No. 110010458; Lot No. 710930; UDI No. (01) 00880304568747 (17) 230614 (10) 710930; EXP Date June 14th 2023    (2) RingLoc Hip system Acetabular Bi-Polar Cup:   Acetabular Cup, ArCom, 41 MM OD,  28 MM ID:  Item No. 11-165206, Lot No. 649750; UDI No. (01) 00880304001923 (17) 230614 (10) 649750; EXP Date June 14th 2023    (3) RingLoc Bi-Polar Hip System Acetabular Cup ArCom:  Acetabular Cup, ArCom, 52 MM OD, 28 MM ID:   Item No. 11-165228; Lot No. 433290; UDI No. (01) 00880304001930 (17) 230612 (10) 433290; EXP Date June 12th 2023"
    }
  ]
}