{
  "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": [
    {
      "country": "United States",
      "city": "Westminster",
      "address_1": "10225 Westmoor Dr",
      "reason_for_recall": "The Vitality Shear-off Set Screw is not threading properly with the mating tulip head of the Vitality screws, hooks and connectors due to a manufacturing issue.These devices are indicated as an adjunct to fusion for various indications",
      "address_2": "",
      "product_quantity": "16,429 devices (Thoracolumbosacral pedicle screw system,Spinal Interlaminal & Spinal Intervertebral Body, both appliances for fixation)",
      "code_info": "Item Number; Lot Number; Item Description; UDI #; Manufacturing Quantity     07.02011.001; P141352 (Z00176603); Vitality Shear-off Set Screw; (01)00889024003187 (10)P141352; 2,192 devices    07.02011.001; P141353; Vitality Shear-off Set Screw; (01)00889024003187 (10)P141353; 879 devices    07.02011.001; P141354 (Z00468651); Vitality Shear-off Set Screw; (01) 00889024003187 (10)P141354;  924 devices    07.02011.001; P141358 (Z00420148); Vitality Shear-off Set Screw; (01)00889024003187 (10)P141358;  2,193 devices    07.02011.001; P141359 (Z00274115); Vitality Shear-off Set Screw; (01)00889024003187 (10)P141359;  868 devices    07.02011.001; P141360; Vitality Shear-off Set Screw; (01)00889024003187 (10)P141360;  872 devices    07.02011.001; P142510; Vitality Shear-off Set Screw; (01)00889024003187 (10)P142510;  3,045 devices    07.02011.001; W505611; Vitality Shear-off Set Screw; (01)00889024003187 (10)W505611;  1,545 devices    07.02011.001; W508041; Vitality Shear-off Set Screw; (01)00889024003187 (10)W508041;  1,497 devices    07.02011.001; W509651; Vitality Shear-off Set Screw; (01)00889024003187 (10)W509651;  3,396 devices    07.02011.001; W509661; Vitality Shear-off Set Screw; (01)00889024003187 (10)W509661;  3,382 devices    07.02011.001; W5096619; Vitality Shear-off Set Screw; (01)00889024003187 (10)W5096619;  61 devices    07.02011.001; W526991; Vitality Shear-off Set Screw; (01)00889024003187 (10)W526991;  799 devices    07.02011.001; W529371; Vitality Shear-off Set Screw; (01)00889024003187 (10)W529371;  823 devices    07.02011.001; W530301; Vitality Shear-off Set Screw; (01)00889024003187 (10)W530301;  1,342 devices    07.02011.001; W546001; Vitality Shear-off Set Screw; (01)00889024003187 (10)W546001;  634 devices    07.02011.001; W554821; Vitality Shear-off Set Screw; (01)00889024003187 (10)W554821;  2,110 devices    07.02011.001; W559871; Vitality Shear-off Set Screw; (01)00889024003187 (10)W559871;  1,461 devices    07.02011.001; W573501; Vitality Shear-off Set Screw; (01)00889024003187 (10)W573501;  2,713 devices    07.02011.001; W573511; Vitality Shear-off Set Screw; (01)00889024003187 (10)W573511;  2,698 devices    07.02011.001; W577991; Vitality Shear-off Set Screw; (01)00889024003187 (10)W577991;  2,026 devices  W508041 (01)00889024003187 (10)W508041  W509661 (01)00889024003187 (10)W509661  W526991 (01)00889024003187 (10)W526991  W530301 (01)00889024003187 (10)W530301  W554821 (01)00889024003187 (10)W554821  W573501 (01)00889024003187 (10)W573501  W577991 (01)00889024003187 (10)W577991",
      "center_classification_date": "20190222",
      "distribution_pattern": "Distributed Nationwide: AL, CA, CO, FL, GA, HI, IA, ID, IL, IN, LA, MA, MD, MI, MN, NC, NJ, NV, NY, OH, OK, PA, SC, TN, TX, WA and  WI.**** International distribution: Australia and EMEA.",
      "state": "CO",
      "product_description": "Vitality¿ Spinal Fixation System.Spinal Intervertebral Body, Appliance, Fixation  (non-sterile). Pedicle screw fixation is indicated for skeletally mature patients and for adolescent patients. For use in Orthopedic medical specialty area. Product Usage: The Vitality Shear-off Set Screw is not threading properly with the mating tulip head of the Vitality screws, hooks and connectors due to a manufacturing issue. These devices are indicated as an adjunct to fusion for various indications",
      "report_date": "20190306",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Zimmer Biomet Spine Inc.",
      "recall_number": "Z-0868-2019",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "82076",
      "termination_date": "20210428",
      "more_code_info": "",
      "recall_initiation_date": "20180730",
      "postal_code": "80021-2702",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}