{
  "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": [
    {
      "status": "Terminated",
      "city": "Warsaw",
      "state": "IN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "67627",
      "recalling_firm": "DePuy Orthopaedics, Inc.",
      "address_1": "700 Orthopaedic Dr",
      "address_2": "N/A",
      "postal_code": "46582-3994",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Worldwide Distribution - USA (nationwide) and Internationally to Canada, Australia, Austria, China, Czech Republic, Denmark, Dubai / UAE, Estonia, France, Germany, Hungary, Iberia, India, Ireland, Israel, Italy, Malaysia, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Russia, Singapore, Slovenia, Spain, South Africa, Sweden, Switzerland, Turkey, United Kingdom, and Vietnam.",
      "recall_number": "Z-1207-2014",
      "product_description": "REF 623421 L S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Left , X-Small,  Sterile R  Qty 1    The S-ROM Hinged knee femoral component is used in revision surgeries when there is significant bone loss or ligament instability and additional support is needed. S-Rom femorals and inserts are brought into nearly every revision case as backup should the MCL become compromised during the procedure. If additional constraint is required the surgeon can use the S-ROM femoral and insert. S-ROM femorals are used in less than 10% of knee revision procedures, but are present almost all the time.",
      "product_quantity": "130",
      "reason_for_recall": "DePuy Orthopaedics has identified the potential for holes to develop in the inner and outer flexible pouches that form the sterile barrier for S-ROM Noiles Rotating Hinge Femur with Pin devices. The outer carton and shrink wrap are intact. A package redesign is underway to resolve this issue. S-ROM Noiles Rotating Hinge Femur with Pin devices will remain in US Distributors inventory during the pa",
      "recall_initiation_date": "20140224",
      "center_classification_date": "20140313",
      "termination_date": "20150303",
      "report_date": "20140319",
      "code_info": "Both left and Right  102935,  110571,  114271,  114274,  114277,  128477,  132946,  142857,  156158,  162498,  162499,  162500,  172191,  172194,  193664,  193668,  217297,  224704,  229189,  229192,  229195,  229196,  236454,  236463,  236466,  241379,  249713,  249714,  249715,  254742,  254743,  260549,  260552,  269715,  269717,  278454,  278456,  283005,  283006,  283007,  291037,  291038,  291039,  295391,  302819,  306516,  306517,  314828,  314831,  314832,  317759,  317761,  317765,  317769,  317770,  317772,  329335,  338170,  338171,  338173,  338176,  346442,  354609,  354614,  360644,  360645,  360646,  360647,  366437,  366439,  366440,  373257,  373258,  378654,  378655,  378657,  378660,  385029,  385031,  385033,  385034,  392028,  392029,  392032,  400543,  400544,  402441,  403009,  403012,  409586,  414761,  414762,  414763,  414764,  414765,  414766,  414767,  430493,  430494,  430495,  430496,  430498,  438592,  438593,  438594,  438595,  438596,  438597,  438598,  438599,  448539,  452452,  453170,  453171,  453172,  456749,  456751,  456752,  456753,  456754,  470494,  470496,  470503,  470504,  D51B54,  D51B64,  D51B84,  D51B94,  DN5ET4,  DY5EP4,  E4EGG4,  E5WCF4,  E6CFK4,  FD6G14,  FE2DP4,  FL8AM4"
    }
  ]
}