{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "West Chester",
      "state": "PA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "73559",
      "recalling_firm": "Synthes (USA) Products LLC",
      "address_1": "1301 Goshen Pkwy",
      "address_2": "N/A",
      "postal_code": "19380-5986",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide: NY, PA, AL, WI, FL, MO, TN, OH, MI, MN, CO, CA, NV, AZ, LA, OR, TX, IA, IN, MS, IL, AR, WV, HI, VA, MD, WA, OK, MA, KY, NJ, CT, No foreign accounts.",
      "recall_number": "Z-1383-2016",
      "product_description": "SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute  Device listing number: D140596, D211012  SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.",
      "product_quantity": "212 units",
      "reason_for_recall": "It was reported that the SYNTHECEL Dura Repair could adhere to various anatomical structures post implantation, which may expose patients to potential risks in the event a surgeon intends to temporarily apply and subsequently remove a SYNTHECEL implant.  SYNTHECEL Dura Repair labeling and promotional material are being updated to clarify that SYNTHECEL is intended to remain in place and is not intended to be removed.",
      "recall_initiation_date": "20151208",
      "center_classification_date": "20160413",
      "termination_date": "20160826",
      "report_date": "20160420",
      "code_info": "SYNTHECEL Dura Repair 2.5 cm x 2.5 cm (1x1), part numbers: SC.400.006.01S, Lot Numbers: 7840311, 7855336, 7860563, 7909569, 7922340, 7932410, 7984104",
      "more_code_info": ""
    }
  ]
}