{
  "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": [
    {
      "status": "Terminated",
      "city": "Plainsboro",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "67350",
      "recalling_firm": "Integra LifeSciences Corp.",
      "address_1": "311 Enterprise Dr",
      "address_2": "N/A",
      "postal_code": "08536-3344",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution - USA including IA, FL, LA, IL, CA, TX, AZ, NC, MD, NM, VA, and Internationally to South Africa.",
      "recall_number": "Z-0938-2014",
      "product_description": "Malibu Polyaxial Screwdriver, 8.0 Plus, Model Number 91-2109;  Malibu Polyaxial Screwdriver, Standard, Model Number 91-2110.    510(k):  91-2109  K061342.  91-2110  K051942.         The Malibu\" System is intended to be used as a temporary or permanent posterior, non-cervical implant to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur. The System is comprised of single use pedicle screws of varying reduction height, rods, rod connectors, etc. and an accompanying set of reusable surgical instruments. Some of the surgical instruments are specific to the system and others are general surgical instruments. The polyaxial screwdriver is specific to the polyaxial screws in the system.",
      "product_quantity": "40",
      "reason_for_recall": "Integra LifeSciences has identified through an investigation of complaints that there may be the potential for the shaft  of the Malibu Polyaxial Drivers to break during use. None of the complaints reported a patient  injury. However, some complaints did indicate the surgery was slightly prolonged while the additional driver provided  in the kit was retrieved and used.",
      "recall_initiation_date": "20140122",
      "center_classification_date": "20140207",
      "termination_date": "20141217",
      "report_date": "20140219",
      "code_info": "Model Number(s):       91-2109 (8.0 Plus)       91-2110 (Standard).    Lot AL549784F:  91-2109 Malibu Polyaxial Screwdriver 8.0 Plus.  Lot AL552404F:  91-2110 Malibu Polyaxial Screwdriver Standard.  Lot AL546768F:  91-2110 Malibu Polyaxial Screwdriver Standard.    The devices are not distributed as sterile and do not have a expiration date."
    }
  ]
}