{
  "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": "An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads.  This impingement may not allow the stem and head to lock as intended.  The amount of possible impingement varies depending on the femoral head.  Worst case condition: Calcar stem with -2mm offset articuleze maximum of 0.937mm radial impingement.  It is evident that a",
      "address_2": "",
      "product_quantity": "1732 total all product codes",
      "code_info": "Product Code: 157225195 and Lot codes: B2WBP1000, B34H81000, B34H8A000, BB1AJ1000, CD1EX1000, D5NEH1000, X4SF21000, X5FBT1000, X5FBTA000, X5FBV1000, X5FBVA000, X5PGM1000, X5PGN1000, X5PGNA000, X83KD1000, YF3E81000, YF6AF1000, YG4AG1000, ZA7JB1000, and ZA7JBA000.",
      "center_classification_date": "20121220",
      "distribution_pattern": "Nationwide Distribution including AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WY and GUAYNABO, PR",
      "state": "IN",
      "product_description": "SOL SYS L 9IN CALC 2.25/19.5    Packaging: Product is packed within a poly protector, with protection added as needed for fragile points.  The entire stem is then placed within a foam sleeve for added protection.  The assembly is then placed and sealed in an inner and outer tray for aseptic transfer.  The sealed package is placed into a folding carton, labeled, and shrink wrapped.      Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) 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": "20121226",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "DePuy Orthopaedics, Inc.",
      "recall_number": "Z-0583-2013",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "63545",
      "termination_date": "20131113",
      "more_code_info": "",
      "recall_initiation_date": "20121203",
      "postal_code": "46582-3994",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}