{
  "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": "Irving",
      "state": "TX",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "85642",
      "recalling_firm": "Acuity Surgical Devices, LLC",
      "address_1": "8710 N Royal Ln",
      "address_2": "N/A",
      "postal_code": "75063-2539",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Other",
      "distribution_pattern": "US Nationwide distribution including in the states of TX, FL, NC, LA, KY, WI, SD, IL, CA, and KS.  O.U.S.: None",
      "recall_number": "Z-2355-2020",
      "product_description": "A LINK Z INTERVERTEBRAL BODY FUSION DEVICE    Product Description:  A Link Z Ti Unitary Open Interbody 32x24x12 7  A Link Z Ti Unitary Open Interbody 32x24x12 12  A Link Z Ti Unitary Open Interbody 32x24x16 7  A Link Z Ti Unitary Open Interbody 32x24x16 12    Product Usage: is a spinal device that is implanted in the intervertebral body space via an anterior approach to improve stability of the spine while supporting fusion.",
      "product_quantity": "A total of 27 lots producing 178 units",
      "reason_for_recall": "Due to a manufacturing process issue, it allowed vertebral body bone screws to not seat properly within the spinal device/cage.",
      "recall_initiation_date": "20190107",
      "center_classification_date": "20200611",
      "report_date": "20200617",
      "code_info": "Product  Product Description                             Lot  Number                                                 Number  15-32241207 A Link Z Ti Unitary Open Interbody 32x24x12 7  1000572  15-32241212 A Link Z Ti Unitary Open Interbody 32x24x12 12         1000573  15-32241607 A Link Z Ti Unitary Open Interbody 32x24x16 7  1000576  15-32241612 A Link Z Ti Unitary Open Interbody 32x24x16 12         1000577"
    }
  ]
}