{
  "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": "2026-04-01",
    "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": "86896",
      "recalling_firm": "Biomet, Inc.",
      "address_1": "56 E Bell Dr",
      "address_2": "N/A",
      "postal_code": "46582-6989",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution. US nationwide, ARGENTINA, AUSTRALIA, Brazil,  CANADA, CHILE, CHINA, COSTA RICA, EMEA, HONG KONG, INDIA, JAPAN, KOREA, MALAYSIA, NEW ZEALAND, SINGAPORE, and TAIWAN",
      "recall_number": "Z-0619-2021",
      "product_description": "Comprehensive Reverse Shoulder System, Item numbers 115394, 115395, 115396, 115398, 180550, 180551, 180552,   180553, 180554, 180555, 180556, 180557, 180558, 180559,   180560, 180562 - Product Usage: indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthroplasty and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff The patient must anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.",
      "product_quantity": "7428",
      "reason_for_recall": "Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.",
      "recall_initiation_date": "20201125",
      "center_classification_date": "20201217",
      "termination_date": "20240508",
      "report_date": "20201223",
      "code_info": "Lots 208000  270240  270260  208010  214760  270290  270300  270310  484060  484150  208130  155060  208270  472020  193140  193200  193220  193300  272150  272290  354260  354350  497880  497910  497930  497970  498680  498690  498700  509140  214470  214490  214500  214520  154290  154300  154360  272530  498790  498800  498860  498870  154420  154430  214610  272620  272680  354050  354090  354110  354120  354130  354150  498880  498890  498910  498920  498940  498960  214630  214640  214650  272730  376710  625850  214660  353570  272770  272840  353600  499060  625860  625870  625880  625900  214700  351300  352990  353620  353650  214710  214720  214730  353230  353240  353270  353280  353300  214740  272920  353310  353340  353350  214750  353370"
    }
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}