{
  "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": "Selzach",
      "state": "N/A",
      "country": "Switzerland",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "81087",
      "recalling_firm": "Stryker GmbH",
      "address_1": "Bohnackerweg 1",
      "address_2": "N/A",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide in the states of CO, FL, MD, MI, NY, OK, and PA.",
      "recall_number": "Z-0288-2019",
      "product_description": "Hoffman LRF Hexapod Strut, Extra Short 89mm-109mm, Model Number 4935-0-010. Product Usage - The Hoffmann LRF System is indicated in pediatric patients and adults for the treatment and fixation of:   Open and closed fractures   Post-traumatic joint contracture which has resulted in loss of range of motion   Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction   Pseudoarthrosis or non-union of long bones   Limb lengthening by epiphyseal, diaphyseal, or metaphyseal distraction   Correction of bony or soft tissue deformity   Correction of segmental bony or soft tissue defects   Joint arthrodesis   Management of communicated intra-articular fractures of the distal radius   Bone transport The Hoffmann LRF System is indicated in adults for:   Osteotomy   Revision procedure where other treatments or devices have been unsuccessful   Bone reconstruction procedures   Fusions and replantations of the foot   Charcot foot reconstruction   Lisfranc dislocations The typical LRF construct features two or more rings bridged by three to four telescopic struts with multiplanar, ball jointed fixation bolts. Once applied, the LRF can be unlocked for gross frame adjustment and fracture reduction. The LRF can be finely adjusted to aid in limb alignment and definitively locked to hold compression and reduction. If deemed appropriate, the LRF Telescopic Struts can provide up to 5mm of controlled dynamization.  Original Statement OP-Tech H-ST-1_Rev2_HoffmannLRF_OpTech_2016-10690]",
      "product_quantity": "578",
      "reason_for_recall": "The press fit connection of the Angular Sleeve and pin of the U-Joint and Click Lock did not meet specification. A dimensional discrepancy of the bore hole of the Angular Sleeve may cause a reduced press fit of the pin. This can result in partial of full displacement or loss of the pin and, accordingly, stability of the strut of the frame cannot be ensured.",
      "recall_initiation_date": "20180828",
      "center_classification_date": "20181029",
      "termination_date": "20210204",
      "report_date": "20181107",
      "code_info": "Lots:  L13687  L22247  L18236  L25182  L31085  L35845  L47079  L47736  L57503  Y00078  Y03126  Y07637  Y07634  Y11976  Y14639  Y14643  Y18430"
    }
  ]
}