{
  "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": "345 E Main St",
      "reason_for_recall": "Zimmer is initiating a lot specific recall of the CPT Hip Stem, Versys Build-Up Block, and Trabecular Metal Reverse Glenosphere medical devices due to reports of the products being packaged in the incorrect outer carton. Product labels and patient labels are correct.",
      "address_2": "",
      "product_quantity": "25",
      "code_info": "Part 00-4349-036-11, Lot 62393502",
      "center_classification_date": "20131230",
      "distribution_pattern": "Worldwide Distribution -USA including OH, FL, WI, MI NJ, SC, CA, NC, PA, OR, WA, TN, KY, OK, KS, AZ, TX, CO, NV and Internationally to Germany.    There have been 71 distribution events.  Note that this product is lot controlled and may be distributed multiple times if it was returned and returned to the shelf. 7 units have been returned, including three through the complaint process, which leaves 64 affected units in the field subject to removal.",
      "state": "IN",
      "product_description": "Trabecular Metal (TM) Reverse Glenosphere 36mm   Part 00-4349-036-11    The reverse shoulder system is used in the treatment of the following: severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint; un-united humeral head fractures of long duration; irreducible 3 and 4-part proximal humeral fractures; avascular necrosis of the humeral head, or other difficult clinical management problems (such as a failed total shoulder arthropolastey or grossly rotator cuff deficient joint) where arthrodesis or resectional arthroplasty is not acceptable. 510(k) K130661",
      "report_date": "20140108",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Zimmer, Inc.",
      "recall_number": "Z-0609-2014",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "66968",
      "termination_date": "20140911",
      "more_code_info": "",
      "recall_initiation_date": "20131210",
      "postal_code": "46580-2746",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}