{
  "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": "2026-09-02",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Durham",
      "state": "NC",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "99402",
      "recalling_firm": "restor3d Inc.",
      "address_1": "4001 E Nc 54 Hwy",
      "address_2": "Suite 3160",
      "postal_code": "27709",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "U.S. Nationwide distribution in the state of Texas.",
      "recall_number": "Z-2987-2026",
      "product_description": "Brand Name: Veritas Standard Reverse Total Shoulder  Product Name: Veritas Standard Glenoid Baseplate  Model/Catalog Number: 1500-1030; 1500-1035  Software Version: N/A - off-the-shelf hardware product  Product Description: The restor3d Reverse Total Shoulder Arthroplasty System is intended for patients requiring a reverse   shoulder replacement for patients with a functional deltoid muscle and with a deficient rotator cuff. The   restor3d Reverse Total Shoulder Arthroplasty System consists of the glenoid baseplate, glenosphere   intraoperatively affixed to the baseplate, humeral stem, and polymer bearing component affixed to the   humeral stem. Additionally, the system includes supporting standard instrument trays and all required   accessories (e.g., security screws, peripheral screws). The restor3d rTSA System is indicated for use in   patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously   failed shoulder joint replacement with a grossly deficient rotator cuff.    The Veritas standard glenoid baseplate is the only component within scope of this field action. The patient-specific baseplate is unaffected by this defect and therefore not in scope.  Component: Reverse Total Shoulder",
      "product_quantity": "59",
      "reason_for_recall": "Due to incorrect machining of peripheral screw hole resulting in potential for improper engagement of the peripheral screws.",
      "recall_initiation_date": "20260630",
      "center_classification_date": "20260819",
      "report_date": "20260826",
      "code_info": "Lot Code: Model No 1500-1030; UDI-DI 00840097513225; Lot Numbers A00030, A00065, A09828, A09830    Model No 1500-1035; UDI-DI 00840097513232; Lot Numbers A00064, A09829",
      "more_code_info": ""
    }
  ]
}