{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Rillieux La Pape",
      "state": "N/A",
      "country": "France",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "92738",
      "recalling_firm": "Medicrea International",
      "address_1": "Vancia",
      "address_2": "Vancia",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US nationwide",
      "recall_number": "Z-2458-2023",
      "product_description": "PASS LP, REF numbers:    a) B02315535Z,   b) B02315540Z,   c) B02315545Z,   d) B02315550Z,   e) B02316535Z,   f) B02316540Z,   g) B02316545Z,   h) B02316550Z,   i) B02317540Z,   j) B02317545Z,   k) B02317550Z; intervertebral fusion device - cervical",
      "product_quantity": "963 units",
      "reason_for_recall": "There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.",
      "recall_initiation_date": "20230712",
      "center_classification_date": "20230824",
      "report_date": "20230830",
      "code_info": "a) B02315535Z, GTIN 03613720185086, Lot Numbers:  21J0184;  b) B02315540Z, GTIN 03613720185116, Lot Numbers:  18E0322, 18F1011, 18G0704, 18I0780, 18K0862, 19B0091, 19B0731, 19D0267, 19F0460, 19J0742, 20A0966, 20F0008, 20I0200, 20I0833, 22I0616;  c) B02315545Z, GTIN 03613720185147, Lot Numbers:  18H0617, 18I0682, 18J0215, 18K0863, 19K0545, 20H0147;  d) B02315550Z, GTIN 03613720185178, Lot Numbers:  19E0306, 20F0009;  e) B02316535Z, GTIN 03613720185321, Lot Numbers:  21J0185, 21J0899;  f) B02316540Z, GTIN 03613720185352, Lot Numbers:  18E0478, 18H0672, 18K0278, 18K0864, 19A0645, 19B0318, 19B0777, 19C0417, 19C0739, 19E0082, 19I0573, 20A0596, 20B0687, 20H0148, 20J0414, 21A0107, 22A0297, 22I0339;  g) B02316545Z, GTIN 03613720185383, Lot Numbers:  18D1035, 18E0508, 18F0534, 18G0170, 18G0591, 18H0588, 18J0054, 18K0279, 18K0865, 19A0066, 19B0093, 19B0912, 19C0138, 19D0177, 19E0084, 19G0188, 19J0227, 19J0228, 19K0764, 19L0360, 19L0580, 20B0688, 20H0151, 20J0415, 20L0238, 21A0109, 21A0642, 21D0174, 21F0505, 21L0394, 22A0047, 22L0091;  h) B02316550Z, GTIN 03613720185413, Lot Numbers:  21A0506, 21C0501;  i) B02317540Z, GTIN 03613720185598, Lot Numbers:  21A0110, 21A0508, 21A0524, 22B0782;  j) B02317545Z, GTIN 03613720185628, Lot Numbers:  20E0097, 21A0076, 21B0498;  k) B02317550Z, GTIN 03613720185659, Lot Numbers:  20C0294, 20H0508, 20J0283, 22B0366"
    }
  ]
}