{
  "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": "Leesburg",
      "state": "VA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "83768",
      "recalling_firm": "K2M, Inc",
      "address_1": "600 Hope Pkwy SE",
      "address_2": "N/A",
      "postal_code": "20175-4428",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Distributed to accounts in AL, CA, CO, FL, IL, KY, LA, MD, MI, MN, MS, NC, NJ, NY, OH, OK, PA, TN, TX, and WA.. Foreign distribution to Australia.",
      "recall_number": "Z-0110-2020",
      "product_description": "YUKON Polyaxial Screws (3.5 X 12 mm, Owning Site: Leesburg USA  3.5 X 14 mm, 3.5 X 32 mm, 3.5 X 34 mm, 3.5 X 38 mm, 3.5 X 40 mm, 4.0 X 16 mm,  4.0 X 18 mm, 4.0 X 20 mm, 4.0 X 22 mm, 4.0 X 24 mm, 4.0 X 26 mm, 4.0 X 28 mm,  4.0 X 30 mm, 5.0 X 22 mm, 5.0 X 28 mm, 5.0 X 30 mm)    Catalog Numbers 7601-03512, 7601-03514,  7601-03532, 7601-03534,  7601-03538L, 7601-03540L,  7601-04016L, 7601-04018L,  7601-04020L, 7601-04022L,  7601-04024L, 7601-04026L,  7601-04028L, 7601-04030,  7601-05022, 7601-05028,  7601-05030",
      "product_quantity": "364",
      "reason_for_recall": "Screws had a manufacturing error that could prevent the screw from mating with the screw inserter or set screw as intended. This event was reported to FDA as part of Stryker's retrospective review of K2M product field actions; the action was completed in 2018.",
      "recall_initiation_date": "20180724",
      "center_classification_date": "20191009",
      "termination_date": "20201001",
      "report_date": "20191016",
      "code_info": "Lots FUVD, FUVE, FUVG, FUWF, FUWK, FUWL, FUWU,  FUWV, FUWW, FUXK, FUXL,FUXM, FUXN, FUXP, FUXR, FUXT, FUXU, FUXV"
    }
  ]
}