{
  "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": "2026-09-10",
    "results": {
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      "cfres_id": "194540",
      "product_res_number": "Z-1375-2022",
      "event_date_initiated": "2022-05-18",
      "event_date_created": "2022-07-12",
      "recall_status": "Open, Classified",
      "res_event_number": "90476",
      "product_code": "LZY",
      "k_numbers": [
        "K903084"
      ],
      "product_description": "MODULAR CATHCART FRACTURE HEAD HIP BALL, sizes 41mm to 60mm inclusive; metallic femoral head prosthesis, Product No. 136341000, 136342000, 136343000, 136344000, 136345000, 136346000, 136347000, 136348000, 136349000, 136350000, 136351000, 136352000, 136353000, 136354000, 136356000, 136358000, 136360000",
      "code_info": "All lots until Instructions for Use (IFU) is revised",
      "firm_fei_number": "1818910",
      "recalling_firm": "DePuy Orthopaedics, Inc.",
      "address_1": "700 Orthopaedic Dr",
      "city": "Warsaw",
      "state": "IN",
      "postal_code": "46582-3994",
      "additional_info_contact": "Kimberly Long\n574-267-8156",
      "reason_for_recall": "The Cathcart Ball has an inherent +5mm offset which is not currently specified in its Instructions for Use or Surgical Technique Guide. The STG has been updated to reflect the clarification that the +5mm offset should be taken into consideration when using a Cathcart head in a construct for hemi-hip arthroplasty procedures.",
      "root_cause_description": "Labeling design",
      "action": "On June 13, 2022, the firm notified distributed recall letters to customers titled URGENT FIELD SAFETY NOTICE. Customers were instructed to contact their local sales consultant to receive a copy of the revised STG (reference document number DSUS/JRC/0317/2044 Rev B). Product is not being removed from the field.",
      "product_quantity": "3488",
      "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Denmark, Finland, Germany, Greece, Guam, Hong Kong, Ireland, Netherlands, New Zealand, Norway, South Africa, Spain, Sweden, Switzerland, United Kingdom.",
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        "device_name": "Prosthesis, Hip, Hemi-, Femoral, Metal Ball",
        "medical_specialty_description": "Orthopedic",
        "regulation_number": "888.3360",
        "device_class": "2",
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