{
  "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": "Terminated",
      "city": "Allendale",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "81096",
      "recalling_firm": "Howmedica Osteonics Corp.",
      "address_1": "2 Pearl Ct",
      "address_2": "N/A",
      "postal_code": "07401-1611",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Other",
      "distribution_pattern": "US Nationwide Distribution.",
      "recall_number": "Z-0207-2019",
      "product_description": "Tritanium TL Steerable Inserter, Cat. No. 48930000, UDI 07613327381900    Product Usage:  The TL Steerable Inserter is a Class 1 instrument which is provided in a non-sterile condition. The inserter is designed to enter the disc space, with a fixed engagement between the inserter and the cage and then rotate for desired placement. The three components of the TL Steerable Inserter System include: 1. TL Steerable Inserter 2. TL Steerable Inserter Inner Shaft 3. TL Steerable Inserter Driver",
      "product_quantity": "58",
      "reason_for_recall": "The firm received complaints related to the locking mechanism on the steerable inserter not functioning as intended. The firm confirmed that the issue is related to lack of lubrication of the instrument.    There are two potential hazards associated with the implant pivoting  unexpectedly during implant insertion into the disc space. First, if the implant  is initially inserted into the disc space via the impaction method and the implant  pivots unexpectedly, the implant potentially may unintentionally contact  sensitive anatomy. Additionally, the user may potentially experience difficulty  positioning the implant within the disc space due to the lack of rigidity.  A third potential hazard is associated with the inserter not unlocking at the  articulating pivot head during implant positioning within the disc space. Once  the implant is in the prepared disc space and contacts the ventral annulus, the  surgeon unlocks the articulating pivot head and positions the implant  perpendicular to the spinous process. The surgeon may then elect to  lock/unlock the articulating pivot head for desired final positioning of the  implant. If the inserter does not unlock during these final implant positioning  steps, the user may potentially implant the cage in a suboptimal  trajectory/placement.",
      "recall_initiation_date": "20180912",
      "center_classification_date": "20181023",
      "termination_date": "20200716",
      "report_date": "20181031",
      "code_info": "All lots"
    }
  ]
}