{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Warsaw",
      "address_1": "700 Orthopaedic Dr",
      "reason_for_recall": "Orthopaedics, Inc.  (DePuy) is issuing a voluntary recall of four lots of the S-ROM\" liner because the Carton label has an Incorrect Color Code Series Designation.  We have received one complaint regarding this issue.",
      "address_2": "",
      "product_quantity": "12 liners",
      "code_info": "Catalogue Lot Number  87-5987 3189424   3312166   3340992   3402685",
      "center_classification_date": "20120920",
      "distribution_pattern": "Nationwide Distribution including the states of MA, TX, OH, CA, and NC.",
      "state": "IN",
      "product_description": "S-Rom¿ Total Hip System Poly Liner    Packaging:   The insert is placed into an inner foil pouch and vacuum sealed; a ring is placed into a Tyvek/PET pouch and sealed; the foil pouch and Tyvek/PET pouch are placed into a nylon outer pouch and sealed.  This is then placed into a folding carton, labeled, and shrink-wrapped.    Description: Total Hip System Poly Dial¿ Liner is part of the S-ROM¿ Total Hip System. The Liner is fitted inside the acetabular shell; and is the bearing surface for the Head on the S-ROM¿ stem. The S-ROM liner is used for total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Intended Use: Total Hip System Poly Dial Liner is part of the S-Rom Total Hip System. The Liner is fitted inside the acetabular shell; and is the bearing surface for the Head on the S-Rom¿ stem. The S Rom liner is used for total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.",
      "report_date": "20120926",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "DePuy Orthopaedics, Inc.",
      "recall_number": "Z-2414-2012",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "62765",
      "termination_date": "20131009",
      "more_code_info": "",
      "recall_initiation_date": "20120822",
      "postal_code": "46582-3994",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}