{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Allendale",
      "address_1": "2 Pearl Ct",
      "reason_for_recall": "Multiple complaints have reported that the hex tip of the torque wrench fracturing during final tightening.",
      "address_2": "",
      "product_quantity": "220 US units; 431 OUS units",
      "code_info": "Medical Device Listing Number  E207315    1)  XIA Torque Wrench  Catalog # 03807028  Lot # 127510, 092793, 097089, 11E038, 11E039, 11E040, 11E041, 123746, 127179, &12D012    2) XIA 3 Torque Wrench  Catalog # 48237028  Lot # 11E042, 11E044, 11E047, 098525, 118823, 11E043, 11E045, 11E046, 11E048, 127647, R127647, 12A646, & R12A646    3) XIA Elegance Short Torque Wrench  Catalog # 482397028  Lot # 11A957, 11E035, 11E036, R11E036, & 121098    4) Mantis Redux Torque Wrench  Reference Number 48287028  Lot # 098401, 125708, 125709, 127051 & 12A641",
      "center_classification_date": "20131121",
      "distribution_pattern": "Worldwide Distribution - USA (nationwide) and Internationally to Argentina, Australia, Canada, Chile, France, Canada, Germany, Hong Kong, Ireland, Italy, Japan, Korea, Netherlands, New Zealand, Spain, Iraq, Egypt, and Turkey.",
      "state": "NJ",
      "product_description": "Stryker  1)  XIA Torque Wrench  2) XIA 3 Torque Wrench  3) XIA Elegance Short Torque Wrench    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 Court Allendale, NJ 07401-1677 USA +1-201-760-8000    XIA 3 Spinal System- Intended for use in the noncervical spine. When used as an anterior/anterolateral and posterior, non cervical pedicle and on-pedicled fixation system, the XIA 3 Spinal system is intended to provide additional support during fusion autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities; degenerate disc disease (DDD) ; spondylolisthesis; trauma spinal stenosis; curvatures; tumor; pseudoarthrosis and failed previous fusion. XIA - Intended for anterior/anterolateral and posterior, non cervical pedicle and non-pedicle fixation of the spine to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease; spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudoarthrosis and failed previous fusion.",
      "report_date": "20131127",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Stryker Spine",
      "recall_number": "Z-0375-2014",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "66657",
      "termination_date": "20161013",
      "more_code_info": "",
      "recall_initiation_date": "20130924",
      "postal_code": "07401-1611",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}