{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Carlsbad",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "93898",
      "recalling_firm": "Alphatec Spine, Inc.",
      "address_1": "1950 Camino Vida Roble",
      "address_2": "",
      "postal_code": "92008-6505",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Worldwide - U.S. Nationwide distribution including in the states of AL, AZ, CA, CO, CT, FL, GA, IA, ID, IN, KS, KY, MD, MI, MN, MS, NC, NH, NV, NY, OH, OK, OR, PA, Puerto Rico, SC, SD, TN, TX, UT, WA and WI. The country of New Zealand.",
      "recall_number": "Z-1182-2024",
      "product_description": "IdentiTi ALIF Standalone Interbody System:  Part Number/Description  132-10-85-250 / IdentiTi ALIF SA Graft Bolt, 08.5 x 25 mm  132-10-85-300 / IdentiTi ALIF SA Graft Bolt, 08.5 x 30 mm  132-10-85-350 / IdentiTi ALIF SA Graft Bolt, 08.5 x 35 mm  132-10-90-250 / IdentiTi ALIF SA Graft Bolt, 09 x 25 mm  132-10-90-300 / IdentiTi ALIF SA Graft Bolt, 09 x 30 mm  132-10-90-350 / IdentiTi ALIF SA Graft Bolt, 09 x 35 mm  232-10-85-250 / IdentiTi ALIF SA Graft Bolt, 08.5 x 25 mm  232-10-85-300 / IdentiTi ALIF SA Graft Bolt, 08.5 x 30 mm  232-10-85-350 / IdentiTi ALIF SA Graft Bolt, 08.5 x 35 mm  232-11-90-250 / IdentiTi ALIF SA Cannulated Graft Bolt, 09 x 25 mm  232-11-90-300 / IdentiTi ALIF SA Cannulated Graft Bolt, 09 x 30 mm  232-11-90-350 / IdentiTi ALIF SA Cannulated Graft Bolt, 09 x 35 mm    The IdentiTi ALIF Standalone Interbody System is an integrated intervertebral body fusion device for use in anterior lumbar interbody fusion (ALIF) procedures.",
      "product_quantity": "12,777 devices",
      "reason_for_recall": "Due to reports of intraoperative graft bolt implantation breakages.",
      "recall_initiation_date": "20240126",
      "center_classification_date": "20240223",
      "report_date": "20240306",
      "code_info": "Part Number / Product Description / UDI-DI Code / Lot Number 132-10-85-250 / IdentiTi ALIF SA Graft Bolt, 08.5 x 25 mm UDI-DI code: 00190376299716 Lot Numbers: 8746709, 8746724, TO00212  132-10-85-300 / IdentiTi ALIF SA Graft Bolt, 08.5 x 30 mm UDI-DI code: 00190376299730 Lot Numbers: 8746710, 8746725, TO00213  132-10-85-350 / IdentiTi ALIF SA Graft Bolt, 08.5 x 35 mm UDI-DI code: 00190376299754 Lot Numbers: 8746711, TO00218  132-10-90-250 / IdentiTi ALIF SA Graft Bolt, 09 x 25 mm UDI-DI code: 00190376299792 Lot Numbers: 8746712  132-10-90-300 / IdentiTi ALIF SA Graft Bolt, 09 x 30 mm UDI-DI code: 00190376299815 Lot Numbers: 6746713  132-10-90-350 / IdentiTi ALIF SA Graft Bolt, 09 x 35 mm UDI-DI code: 00190376299839 Lot Numbers: 8746714  232-10-85-250 / IdentiTi ALIF SA Graft Bolt, 08.5 x 25 mm UDI-DI code: 00190376369976 Lot Numbers: TO00373, TO00670, TO00694, TO00834, TO01038, TO01404, TO01514, TO01572, TO01573, TO01696, TO01974, TO01979, TO01982, TO02297, TO02393, TO03218, TO03465  232-10-85-300 / IdentiTi ALIF SA Graft Bolt, 08.5 x 30 mm UDI-DI code: 00190376369990 Lot Numbers: TO00376, TO00671, TO00695, TO00710, TO00835, TO01039, TO01405, TO01515, TO01574, TO01575, TO01697, TO01975, TO01980, TO01983, TO02298, TO02394, TO03219, TO03466  232-10-85-350 / IdentiTi ALIF SA Graft Bolt, 08.5 x 35 mm UDI-DI code: 00190376370019 Lot Numbers: TO00380, TO00672, TO00696, TO00836, TO01576, TO01577, TO02163, TO02395  232-11-90-250 / IdentiTi ALIF SA Cannulated Graft Bolt, 09 x 25 mm UDI-DI code: 00190376370293 Lot Numbers: TO00381, TO00673, TO00697, TO01277, TO01578, TO02396  232-11-90-300 / IdentiTi ALIF SA Cannulated Graft Bolt, 09 x 30 mm UDI-DI code: 00190376370316 Lot Numbers: TO00382, TO00674, TO00698, TO01040, TO01406, TO02164, TO02397, TO03220  232-11-90-350 / IdentiTi ALIF SA Cannulated Graft Bolt, 09 x 35 mm UDI-DI code: 00190376370330 Lot Numbers: TO00383, TO00699, TO01407, TO02398",
      "more_code_info": ""
    }
  ]
}