{
  "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": [
    {
      "country": "United States",
      "city": "Mahwah",
      "address_1": "325 Corporate Drive",
      "reason_for_recall": "Stryker Orthopaedics received a report indicating that a Tibial Keel Punch could not be inserted into the slot of the Tibial Punch Tower.  The slot that guides the stem of the keel punch into the channel of the tower was later determined to be undersized.",
      "address_2": "",
      "product_quantity": "152 units",
      "code_info": "Catalog Number 8000-1089.  Lot Number(s):  RD6E087, RD6E187; RD6E083; RD6E082; RD6C178; RD5W268; RD5W267; RD5V260; RD5W320; RD5V240; RD5V239; RD5V238; RD5N407; RD5S104; RD5S103; RD5T177; RD5T179; RD5S259; RD5T178; RD5N406; RD5S300; RD5T298; RD5W381; RD6E086; RD6E089; RD6E090; RD6E091; RD6E158; RD6E159; RD6E160; RD6E186.",
      "center_classification_date": "20120726",
      "distribution_pattern": "Worldwide Distribution",
      "state": "NJ",
      "product_description": "Tibial Punch Tower Assembly.  Non-Sterile.  CAT NO. 8000-1089.  Howmedica Osteonics Corp., 59 Route 17, Allendale, NJ  07401.      During primary Scorpio TKA procedures, the Scorpio Tibial Punch Tower (8000-1089) is used in conjunction with Scorpio Tibial Keel Punches (3760-0305/-0709/-1113 and 3761-0305/-0709/-1113) and Tibial Templates (3750-0003/-0005/-0007/-0009/-0013) to prepare the tibia for baseplate implantation. Per the surgical protocol for Duracon and Scorpio Total Knee Systems with Xcelerate Instrumentation (LSPK31 03/03), tibial templates are used to determine the appropriate coverage of the tibial plateau. Once a template size is selected, the device is secured to the plateau with fixation pins, and the tibial punch tower is assembled by placing the tower onto the two small locating pins on the tibial template. A keel punch is then selected, assembled into the channel of the tower, and impacted with a mallet. Depending on the intended implant size, several keel punches of increasing size may be utilized to incrementally enlarge the cavity. Each keel punch is advanced until it fully seats on the tibial template. Tibial preparation is considered complete when the final keel punch fully seats on the tibial template.",
      "report_date": "20120801",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Stryker Howmedica Osteonics Corp.",
      "recall_number": "Z-2084-2012",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "62365",
      "termination_date": "20130613",
      "more_code_info": "",
      "recall_initiation_date": "20111222",
      "postal_code": "07430",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}