{
  "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": "Mahwah",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "87517",
      "recalling_firm": "Howmedica Osteonics Corp.",
      "address_1": "325 Corporate Dr",
      "address_2": "N/A",
      "postal_code": "07430-2006",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Distribution in US to: CA,, GA, NC, NJ, NV, OK, TX, and to Canada",
      "recall_number": "Z-1379-2021",
      "product_description": "Trial Cutting Guide for Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System, prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.  Catalog Number:\t  I-K3834CG00\t        Specialty Triathlon TS Trial Cutting Guide Set  I-K3834CG1L      \tSpecialty Triathlon TS Trial Cutting Guide Size 1 Left  I-K3834CG1R     \tSpecialty Triathlon TS Trial Cutting Guide Size 1 Right  I-K3834CG2L      \tSpecialty Triathlon TS Trial Cutting Guide Size 2 Left  I-K3834CG2R     \tSpecialty Triathlon TS Trial Cutting Guide Size 2 Right  I-K3834CG3L      \tSpecialty Triathlon TS Trial Cutting Guide Size 3 Left  I-K3834CG3R     \tSpecialty Triathlon TS Trial Cutting Guide Size 3 Right  I-K3834CG4L      \tSpecialty Triathlon TS Trial Cutting Guide Size 4 Left  I-K3834CG4R     \tSpecialty Triathlon TS Trial Cutting Guide Size 4 Right  I-K3834CG5L      \tSpecialty Triathlon TS Trial Cutting Guide Size 5 Left  I-K3834CG5R     \tSpecialty Triathlon TS Trial Cutting Guide Size 5 Right  I-K3834CG6L      \tSpecialty Triathlon TS Trial Cutting Guide Size 6 Left  I-K3834CG6R     \tSpecialty Triathlon TS Trial Cutting Guide Size 6 Right  I-K3834CG7L      \tSpecialty Triathlon TS Trial Cutting Guide Size 7 Left  I-K3834CG7R     \tSpecialty Triathlon TS Trial Cutting Guide Size 7 Right  I-K3834CG8L      \tSpecialty Triathlon TS Trial Cutting Guide Size 8 Left  I-K3834CG8R     \tSpecialty Triathlon TS Trial Cutting Guide Size 8 Right",
      "product_quantity": "113 components",
      "reason_for_recall": "The posterior condyle of the Specialty Triathlon TS Trial Cutting Guide(s), sizes 1 through 8, (Left and Right) has the potential to fracture at the augment cut slot. This can occur in the Trial Cutting Guide packaging during transport or during impaction of the instrument in surgery.",
      "recall_initiation_date": "20210305",
      "center_classification_date": "20210408",
      "termination_date": "20240510",
      "report_date": "20210414",
      "code_info": "All Lot numbers for each GTIN:  GTIN: 07613327327595  GTIN: 07613327327533  GTIN: 07613327327748  GTIN: 07613327329209  GTIN: 07613327329193  GTIN: 07613327329100  GTIN: 07613327329087  GTIN: 07613327329063  GTIN: 07613327328899  GTIN: 07613327328868  GTIN: 07613327328707  GTIN: 07613327328691  GTIN: 07613327328592  GTIN: 07613327328530  GTIN: 07613327328639  GTIN: 07613327328424  GTIN: 07613327328288"
    }
  ]
}