{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "176931",
      "product_res_number": "Z-0349-2020",
      "event_date_initiated": "2019-09-05",
      "event_date_created": "2019-11-08",
      "recall_status": "Terminated",
      "event_date_terminated": "2020-06-23",
      "res_event_number": "83991",
      "product_code": "N/A",
      "product_description": "MODIFIED INSTRUMENTS:\nTrial Spacer 7mm with T-Handle\nTrial Spacer 8mm with T-Handle\nTrial Spacer 9mm with T-Handle\nTrial Spacer 10mm with T-Handle\nTrial Spacer 11mm with T-Handle\nTrial Spacer 12mm with T-Handle\nTrial Spacer 13mm with T-Handle\nTrial Spacer 15mm with T-Handle\nTrial Spacer 17mm with T-Handle",
      "code_info": "Unknown",
      "firm_fei_number": "3008812560",
      "recalling_firm": "Synthes (USA) Products LLC",
      "address_1": "1301 Goshen Pkwy",
      "city": "West Chester",
      "state": "PA",
      "postal_code": "19380-5986",
      "reason_for_recall": "Modified outside of approved manufacturing process",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "DePuy Synthes notified account by letter dated 10/4/19 stating reason for recall, health risk and action take: The modified instruments were removed from your facility on September 5, 2019. Please complete the Business Reply Form acknowledging that the modified instruments are not in the possession of your facility. Return the completed Business Reply Form to you sales consultant or email to DPYUS-SpineFieldActions@its.jnj.com within five (5) business days of this notice. Questions, or become aware of an adverse event associated with the subject devices, please call our Recall Hotline at 610-719-5450 (8 am  5 pm, Eastern time, M-F) or contact your DePuy Synthes Sales Consultant.",
      "product_quantity": "9 units",
      "distribution_pattern": "AR",
      "openfda": {}
    }
  ]
}