{
  "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": "63973",
      "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": "Letter",
      "distribution_pattern": "Worldwide Distribution - USA Nationwide.",
      "recall_number": "Z-0971-2013",
      "product_description": "Specialist 2 IM Rod,  Non-Sterile and associated Surgical Techniques:  Sigma HP Instruments Classic Surgical Technique,0612-89-510  Sigma HP Instruments Balanced Surgical Technique, 0612-88-510  Sigma HP Instruments Fixed Reference Surgical Technique, 0612-87-510  PFC Sigma Knee Systems Primary Cruciate-Retaining & Cruciate-Substituting Procedure Surgical Technique,SP2-007      Product Usage:  The SP2 IM Rod is used in both primary and revision Sigma knee procedures to align the femoral locating device and distal femoral cutting block. It is also used with the IM tibial resection. This rod is included in both the SP2 and HP instrument kits.",
      "product_quantity": "4000; 2600 in USA",
      "reason_for_recall": "Potential for the IM rod to break, leaving fragments in the patient. Surgical Techniques guidance has been updated until design changes can be made to reduce likelihood of potential failure.",
      "recall_initiation_date": "20130205",
      "center_classification_date": "20130318",
      "termination_date": "20140106",
      "report_date": "20130327",
      "code_info": "Product Code 96-6120  Label code / Etch code  C3JHN4 H0808  C3JHS4 H0908  C3JHF4 H1008  C4GA54   C4GCC4   C4GBT4   C52F74 H1108  C52GV4 H1208  C52GL4   C67N14   C98CS4 H0109  C98BF4   DE5P34 H0309  DE5RP4   DF4H44   DG9LK4 H0409  DG9L64   DJ5E34   DK3E34 H0509  DK3FE4   EB5FV4 H0210  D95AN4   EB5GH4 H0310  EC9JY4   EF4DJ4   EJ7AP4 H0410  ES2G64 H0510  EJ7A34   ES2HA4 H0610  ES2HY4 H0710  EX5L44   EX5MS4 H0810  E2SD44 H0910  FA4G94 H0211  FD8MP4 H0311  FH8JA4   FH8JX4 H0611  TBACC TBACC  TBACZ TBACZ  FJ4E74 TBAGG"
    }
  ]
}