{
  "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": "2026-05-06",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Allendale",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "62663",
      "recalling_firm": "Stryker Spine",
      "address_1": "2 Pearl Ct",
      "address_2": "N/A",
      "postal_code": "07401-1611",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Distributed in Atlanta, Georgia.",
      "recall_number": "Z-2235-2012",
      "product_description": "The Instructions For Use for the following:  Stryker TRIO+ 4.5 x 45 mm STANDARD POST SCREW  Stryker TRIO+ 4.5 x 50 mm STANDARD POST SCREW  Stryker TRIO+ 4.5 x 55 mm STANDARD POST SCREW  Stryker TRIO+ 5.5 x 45 mm STANDARD POST SCREW  Stryker TRIO+ 5.5 x 60 mm STANDARD POST SCREW    Manufactured by: STRYKER Spine SAS, Z.I. Marticot - 33610 - Cestas-France +33 (0)5.57.97.06.30 http://www.stryker.com    Distributed in the USA by: Stryker Spine, 2 Pearl Ct., Allendale, NJ 07401-1677 USA +1-201-750-8000.    The system is intended for posterior, non-cervical pedicle and non-pedicle pedicle fixation of the spine. It is indicated for: degenerative disc disease (DDD), spondylolisthesis, fracture, dislocation, spinal stenosis, scoliosis kyphosis, lordosis, spinal tumor, pseudarthrosis, and failed previous fusion.",
      "product_quantity": "40 units.",
      "reason_for_recall": "The front cover of Instructions For Use (IFU) #NOLI135B03Rev02 was improperly marked with a \"Sterile\" logo in the lower right corner.  The products these IFUs were packed with are sold as \"Non-Sterile\" and require sterilization before use in surgery.",
      "recall_initiation_date": "20120425",
      "center_classification_date": "20120821",
      "termination_date": "20130227",
      "report_date": "20120829",
      "code_info": "Code information listed in the following format:  Manufacturer Part Number/Prodcut Description/Corresponding IFU Part Number/Affected Lot #s are as follows:    48900445/Trio Standard Post Screw 5.5x55mm/#NOLI135B03Rev02/57281 and 57201    48900450/Trio Standard Post Screw 5.5x60mm/#NOLI135B03Rev02/57197     48900455/Trio Standard Post Screw 4.5x45mm/#NOLI135B03Rev02/57198    48900555/Trio Standard Post Screw 4.5x50mm/#NOLI135B03Rev02/56599    48900560/Trio Standard Post Screw 4.5x55mm/#NOLI135B03Rev02/57192"
    }
  ]
}