{
  "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-2354-2020",
      "product_description": "A LINK Z INTERVERTEBRAL BODY FUSION DEVICE    Product Description:  A Link Z Ti Unitary Plate-Cage 32x21x15 7  A Link Z Ti Unitary Plate-Cage 32x21x15 12  A Link Z Ti Unitary Plate-Cage 32x21x15 16  A Link Z Ti Unitary Plate-Cage 32x21x15 16  A Link Z Ti Unitary Plate-Cage 32x21x15 16  A Link Z Ti Unitary Plate-Cage 32x21x15 20  A Link Z Ti Unitary Plate-Cage 32x21x15 20  A Link Z Ti Unitary Plate-Cage 32x21x15 20  A Link Z Ti Unitary Plate-Cage 32x21x17 12  A Link Z Ti Unitary Plate-Cage 32x21x17 16  A Link Z Ti Unitary Plate-Cage 32x21x17 20  A Link Z Ti Unitary Plate-Cage 32x21x19 20  A Link Z Ti Unitary Plate-Cage 32x24x15 7  A Link Z Ti Unitary Plate-Cage 32x24x15 16  A Link Z Ti Unitary Plate-Cage 36x26x15 12  A Link Z Ti Unitary Plate-Cage 36x26x15 12  A Link Z Ti Unitary Plate-Cage 36x26x15 16  A Link Z Ti Unitary Plate-Cage 36x26x15 16  A Link Z Ti Unitary Plate-Cage 36x26x15 16  A Link Z Ti Unitary Plate-Cage 36x26x15 16  A Link Z Ti Unitary Plate-Cage 36x26x15 20  A Link Z Ti Unitary Plate-Cage 36x26x15 20  A Link Z Ti Unitary Plate-Cage 36x26x15 20  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  14-32211507 A Link Z Ti Unitary Plate-Cage 32x21x15 7          1000638  14-32211512 A Link Z Ti Unitary Plate-Cage 32x21x15 12     1000259  14-32211516 A Link Z Ti Unitary Plate-Cage 32x21x15 16    1000260  14-32211516 A Link Z Ti Unitary Plate-Cage 32x21x15 16    1000325  14-32211516 A Link Z Ti Unitary Plate-Cage 32x21x15 16    1000529  14-32211520 A Link Z Ti Unitary Plate-Cage 32x21x15 20    1000261  14-32211520 A Link Z Ti Unitary Plate-Cage 32x21x15 20    1000469  14-32211520 A Link Z Ti Unitary Plate-Cage 32x21x15 20    1000556  14-32211712 A Link Z Ti Unitary Plate-Cage 32x21x17 12    1000262  14-32211716 A Link Z Ti Unitary Plate-Cage 32x21x17 16    1000640  14-32211720 A Link Z Ti Unitary Plate-Cage 32x21x17 20    1000641  14-32211920 A Link Z Ti Unitary Plate-Cage 32x21x19 20    1000530  14-32241507 A Link Z Ti Unitary Plate-Cage 32x24x15 7          1000211  14-32241516 A Link Z Ti Unitary Plate-Cage 32x24x15 16    1000536  14-36261512 A Link Z Ti Unitary Plate-Cage 36x26x15 12    1000282  14-36261512 A Link Z Ti Unitary Plate-Cage 36x26x15 12    1000583  14-36261516 A Link Z Ti Unitary Plate-Cage 36x26x15 16    1000232  14-36261516 A Link Z Ti Unitary Plate-Cage 36x26x15 16    1000383  14-36261516 A Link Z Ti Unitary Plate-Cage 36x26x15 16    1000479  14-36261516 A Link Z Ti Unitary Plate-Cage 36x26x15 16    1000652  14-36261520 A Link Z Ti Unitary Plate-Cage 36x26x15 20    1000233  14-36261520 A Link Z Ti Unitary Plate-Cage 36x26x15 20    1000360  14-36261520 A Link Z Ti Unitary Plate-Cage 36x26x15 20    1000584  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"
    }
  ]
}