{
  "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": "Ongoing",
      "city": "West Chester",
      "state": "PA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "89428",
      "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": "US Nationwide distribution.",
      "recall_number": "Z-0634-2022",
      "product_description": "Universal Chuck-The Universal Chuck is an Instrument Handle provided as an alternative instrument available for use in the TN-ADVANCED\" Tibial Nailing System (TNA), TFN-ADVANCED\" Proximal Femoral Nailing System (TFNA), RFN-ADVANCED\" Retrograde Femoral Nailing System (RFNA), FRN-ADVANCED\" Femoral Recon Nailing System (FRNA), and Flexible Monobloc Reamers. Instrument Handles are intended for holding instruments for manipulation during orthopedic surgery.    Product No.: 03.043.001",
      "product_quantity": "600 units",
      "reason_for_recall": "Top cap may loosen and detach if the Universal Chuck becomes jammed and the user attempts to manually free the device, internal ball bearings may fall out onto the surgical field and cause surgical delay or, and if not recovered, adverse tissue  reaction and infection.",
      "recall_initiation_date": "20211222",
      "center_classification_date": "20220210",
      "report_date": "20220216",
      "code_info": "Lot/Serial No.: 20013101, 20052701, 20228901, 20229301, 20253901, 20558602, 20698102, 20777201 21869701, 21983904, 21995301  GTIN: 10886982297372"
    }
  ]
}