{
  "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-0289-2019",
      "product_description": "Hoffman LRF Hexapod Strut, Extra Short 105mm-139mm, Model Number 4935-0-020. 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": "832",
      "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:  L18237  L13688  L22248  L25187  L31271  L35846  L46782  L47078  L47196  L50180  L51361  L53108  L53489  L57504  L58108  L57506  Y00082  Y02871  Y03127  Y08559  Y08560  Y12875  Y14371  Y14640  Y14644  Y14645"
    }
  ]
}