{
  "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": "Palm Beach Gardens",
      "state": "FL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "91070",
      "recalling_firm": "Integrity Implants Inc.",
      "address_1": "354 Hiatt Drive",
      "address_2": "N/A",
      "postal_code": "33418",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Nationwide distribution to AZ, CA, CT, DC, FL, IL, IN, LA, MA, MN, NJ, OK, PR, TN, TX, VA.",
      "recall_number": "Z-0420-2023",
      "product_description": "LineSider Spinal System 5.5/6.0mm, Non-mod MIS 7.1mm - Dual Lead, Cannulated.  Thoracolumbosacral pedicle screw system; Spinal interlaminal fixation orthosis.  Product sold as non-sterile and shipped in protective sterilization trays.  Screws can also be shipped individually, as tray replenishments.  Labeled as the following sizes:      a. 5.5mm x 35mm;      b. 5.5mm x 40mm;      c. 5.5mm x 45mm;      d. 5.5mm x 50mm;      e. 6.5mm x 35mm;      f. 6.5mm x 40mm;      g. 6.5mm x 45mm;      h. 6.5mm x 50mm;      i. 6.5mm x 55mm;      j. 7.5mm x 35mm;      k. 7.5mm x 40mm;      l. 7.5mm x 45mm;      m. 7.5mm x 50mm;      n. 7.5mm x 55mm;      o. 8.5mm x 35mm;      p. 8.5mm x 40mm;      q. 8.5mm x 45mm;      r. 8.5mm x 50mm;      s.8.5mm x 55mm;       t. 9.5mm x 35mm;      u. 9.5mm x 40mm;      v. 9.5mm x 45mm;      w. 9.5mm x 50mm;      x. 9.5mm x 55mm;      Used in spinal fixation surgery.",
      "product_quantity": "1,369 screws",
      "reason_for_recall": "Potential for weld separation of the Upper Tulip Head component from the Lower Tulip Head component, which would result in the separation of the Tulip Head from the Screw Shank.",
      "recall_initiation_date": "20220127",
      "center_classification_date": "20221205",
      "termination_date": "20231023",
      "report_date": "20221214",
      "code_info": "a. 5.5mm x 35mm, Part Number: LS-N6MG5535, UDI: (01)00818613028898(10)02210093, lot Number: 2210093; UDI: (01)00818613028898(10)10200053, Lot Number: 10200053.    b. 5.5mm x 40mm, Part Number: LS-N6MG5540, UDI: (01)00818613028904(10)02210094, lot Number: 2210094; UDI: (01)00818613028904(10)10200054, Lot Number: 10200054.    c. 5.5mm x 45mm, Part Number: LS-N6MG5545, UDI: (01)00818613028911(10)02210095, lot Number: 2210095; UDI: (01)00818613028911(10)10200055, Lot Number: 10200055.    d. 5.5mm x 50mm, Part Number: LS-N6MG5550, UDI: (01)00818613028928(10)02210096, lot Number: 2210096; UDI: (01)00818613028928(10)10200056, Lot Number: 10200056.    e. 6.5mm x 35mm, Part Number: LS-N6MG6535, UDI: (01)00818613028973(10)02210097, lot Number: 2210097; UDI: (01)00818613028973(10)10200057, Lot Number: 10200057; UDI: (01)00818613028973(10)10200057-1, Lot Number: 10200057-1.    f. 6.5mm x 40mm, Part Number: LS-N6MG6540, UDI: (01)00818613028980(10)02210098, lot Number: 2210098; UDI: (01)00818613028980(10)10200058, Lot Number: 10200058; UDI: (01)00818613028980(10)10200058-1, Lot Number: 10200058-1.    g. 6.5mm x 45mm, Part Number: LS-N6MG6545, UDI: (01)00818613028997(10)02210099, lot Number: 2210099; UDI: (01)00818613028997(10)10200059, Lot Number: 10200059; UDI: (01)00818613028997(10)10200059-1, Lot Number: 10200059-1.    h. 6.5mm x 50mm, Part Number: LS-N6MG6550, UDI: (01)008181613029000(10)02210100, lot Number: 2210100; UDI: (01)00818613029000(10)10200060, Lot Number: 10200060; UDI: (01)00818613029000(10)10200060-1, Lot Number: 10200060-1.    i. 6.5mm x 55mm, Part Number: LS-N6MG6555, UDI: (01)00818613029017(10)02210101, lot Number: 2210101; UDI: (01)00818613029017(10)10200061, Lot Number: 10200061.    j. 7.5mm x 35mm, Part Number: LS-N6MG7535, UDI: (01)00818613026528(10)02210102, lot Number: 2210102; UDI: (01)00818613026528(10)10200062, Lot Number: 10200062.    k. 7.5mm x 40mm, Part Number: LS-N6MG7540, UDI: (01)00818613026535(10)02210103, lot Number: 2210103; UDI: (01)00818613026535(10)10200063, Lot Number: 10200063; UDI: (01)00818613026535(10)06210309, Lot Number: 6210309.    l. 7.5mm x 45mm, Part Number: LS-N6MG7545, UDI: (01)00818613026542(10)02210104, lot Number: 2210104; UDI: (01)00818613026542(10)10200064, Lot Number: 10200064; UDI: (01)00818613026542(10)10200064-1, Lot Number: 10200064-1.    m. 7.5mm x 50mm, Part Number: LS-N6MG7550, UDI: (01)00818613026559(10)02210105, lot Number: 2210105; UDI: (01)00818613026559(10)10200065, Lot Number: 10200065; UDI: (01)00818613026559(10)10200065-1, Lot Number: 10200065-1.    n. 7.5mm x 55mm, Part Number: LS-N6MG7555, UDI: (01)00818613026566(10)02210106, lot Number: 2210106; UDI: (01)00818613026566(10)10200066, Lot Number: 10200066.    o. 8.5mm x 35mm, Part Number: LS-N6MG8535, UDI: (01)00818613026597(10)02210107, lot Number: 2210107; UDI: (01)00818613026597(10)10200067, Lot Number: 10200067.    p. 8.5mm x 40mm, Part Number: LS-N6MG8540, UDI: (01)00818613026603(10)02210108, lot Number: 2210108; UDI: (01)00818613026603(10)10200068, Lot Number: 10200068.    q. 8.5mm x 45mm, Part Number: LS-N6MG8545, UDI: (01)00818613026610(10)02210109, lot Number: 2210109; UDI: (01)00818613026610(10)10200069, Lot Number: 10200069.    r. 8.5mm x 50mm, Part Number: LS-N6MG8550, UDI: (01)00818613026627(10)02210110, lot Number: 2210110; UDI: (01)00818613026627(10)10200070, Lot Number: 10200070.    s. 8.5mm x 55mm, Part Number: LS-N6MG8555, UDI: (01)00818613026634(10)02210111, lot Number: 2210111; UDI: (01)00818613026634(10)10200071, Lot Number: 10200071.     t. 9.5mm x 35mm, Part Number: LS-N6MG9535, UDI: (01)00818613026658(10)02210112, lot Number: 2210112; UDI: (01)00818613026658(10)10200072, Lot Number: 10200072.    u. 9.5mm x 40mm, Part Number: LS-N6MG9540, UDI: (01)00818613026665(10)02210113, lot Number: 2210113; UDI: (01)00818613026665(10)10200073, Lot Number: 10200073.    v. 9.5mm x 45mm, Part Number: LS-N6MG9545, UDI: (01)00818613026672(10)02210114, lot Number: 2210114; UDI: (01)00818613026672(10)10200074, Lot Number: 10200074.    w. 9.5mm x 50mm, Part Number: LS-N6MG9550, UDI: (01)00818613026689(10)02210115, lot Number: 2210115; UDI: (01)00818613026689(10)10200075, Lot Number: 10200075.    x. 9.5mm x 55mm, Part Number: LS-N6MG9555, UDI: (01)00818613026696(10)02210116, lot Number: 2210116; UDI: (01)00818613026696(10)10200076, Lot Number: 10200076."
    }
  ]
}