{
  "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": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "149824",
      "product_res_number": "Z-0136-2017",
      "event_date_initiated": "2016-09-14",
      "event_date_created": "2016-10-18",
      "recall_status": "Terminated",
      "event_date_terminated": "2016-11-15",
      "res_event_number": "75255",
      "product_code": "JEC",
      "k_numbers": [
        "K984442"
      ],
      "product_description": "Agee-WristJack Fracture Reduction System;\nItem number: CFD-147.\nThe WristJack Fracture Reduction System is a fracture reduction and external fixation system for treatment of distal radius fractures. This is a single use system used for a trauma related surgery\n\nThe WristJack Fracture Reduction System is a fracture reduction and external fixation system for treatment of distal radius fractures. The non-perishable sterile system is packaged in an inner then outer tray and shipped in a cardboard shelf box.\n\nOrthopedic:The WristJack Fracture Reduction System is a fracture reduction and external fixation system for treatment of distal radius fractures.",
      "code_info": "Lot number: HBL-115-165, serial numbers 47460959 and 47460980; Lot number: HBL-116-014 - all serial numbers; Lot number : HBL-116-040 - 15 systems shipped prior to recall",
      "firm_fei_number": "2919128",
      "recalling_firm": "Hand Biomechanics Lab Inc",
      "address_1": "77 Scripps Dr Ste 104 77 Scripps Dr",
      "address_2": "Ste 104",
      "city": "Sacramento",
      "state": "CA",
      "postal_code": "95825-6209",
      "additional_info_contact": "Dustin Dequine\n916-923-5073",
      "reason_for_recall": "A number of Agee WristJack Fracture Reduction Systems have been manufactured with a molded beam slightly larger than optimal. This may result in the surgeon experiencing difficulty fine-tuning the length (red) and radial/ulnar alignment (blue) adjustments on the device.",
      "root_cause_description": "Under Investigation by firm",
      "action": "Hand Biomechanics Lab, Inc. sent a Voluntary Medical Device Recall letter to all affected customers beginning on September 14, 2016 and sent by phone/fax numbers - or e-mail. Letters request return of devices which have not yet been used.  Customers with questions were instructed to contact Customer Service at (800) 522-5778.\nFor questions regarding this recall call 916-923-5073.",
      "product_quantity": "65 units",
      "distribution_pattern": "Nationwide Distribution",
      "openfda": {
        "k_number": [
          "K781793",
          "K781839",
          "K203605",
          "K954838",
          "K914858",
          "K802722",
          "K884798",
          "K032427",
          "K922796",
          "K822780",
          "K952730",
          "K791466",
          "K842343",
          "K013818",
          "K901984",
          "K833114",
          "K072432",
          "K930153",
          "K991732",
          "K934698",
          "K944092",
          "K880282",
          "K042066",
          "K800184",
          "K981423",
          "K802814",
          "K802723",
          "K894982",
          "K965029",
          "K920149",
          "K936045",
          "K022065",
          "K943857",
          "K984442",
          "K803166",
          "K022676",
          "K003848",
          "K884242",
          "K852397",
          "K872538",
          "K790262",
          "K894959",
          "K961618",
          "K840856",
          "K971755",
          "K781841",
          "K952330",
          "K903105",
          "K882877",
          "K030519",
          "K936124",
          "K031941",
          "K830154",
          "K082679",
          "K961916",
          "K761088",
          "K770388",
          "K931578",
          "K132731",
          "K171863",
          "K071476",
          "K963614",
          "K841334",
          "K920117",
          "K102885",
          "K933968",
          "K831576",
          "K192465",
          "K781840",
          "K960782",
          "K012193",
          "K770066",
          "K954667",
          "K163028",
          "K894098",
          "K842493",
          "K993099",
          "K193256",
          "K181192",
          "K881896",
          "K881673",
          "K802776",
          "K892638",
          "K915800",
          "K792561"
        ],
        "registration_number": [
          "3033509898",
          "3032391",
          "3010860227",
          "3008868758",
          "1526534",
          "1047843",
          "2032112",
          "1720929",
          "2032098",
          "9680825",
          "1043534",
          "3005061536",
          "3008534770",
          "1818910",
          "3013004243",
          "3025141",
          "1828464",
          "3005893246",
          "3006015326",
          "3036756245",
          "3006946279",
          "1834379",
          "3035366890",
          "3000270450",
          "1043653",
          "9610905",
          "3015542154",
          "2531232",
          "3013055499",
          "3009350690",
          "3023852420",
          "1423662",
          "8031020",
          "3008114965",
          "2183449",
          "2090040",
          "2011171",
          "3008812560",
          "3004464325",
          "3013176080",
          "1220246",
          "3003860203",
          "3011683674",
          "2031910",
          "1825034",
          "3006694268",
          "2029275",
          "3010667733",
          "1828288",
          "1054811",
          "3034676720",
          "2919128",
          "3015207155",
          "1066368",
          "3011500362",
          "1057946",
          "1526439",
          "3015882686",
          "3025603301",
          "3010287687",
          "2028632",
          "3009417901"
        ],
        "fei_number": [
          "3033509898",
          "3002299608",
          "1000125930",
          "3010860227",
          "3008868758",
          "1526534",
          "3002807827",
          "1047843",
          "3003076831",
          "1720929",
          "1043534",
          "3002926812",
          "3005061536",
          "3008534770",
          "1818910",
          "3013004243",
          "3002807830",
          "1828464",
          "3005893246",
          "3006015326",
          "3036756245",
          "3006946279",
          "3035366890",
          "1000525271",
          "3000270450",
          "3003346235",
          "1043653",
          "3015542154",
          "3002807464",
          "3000215273",
          "3009350690",
          "3013055499",
          "3023852420",
          "3008114965",
          "1000114185",
          "3002615969",
          "2183449",
          "2011171",
          "3008812560",
          "3004464325",
          "3013176080",
          "1220246",
          "3003860203",
          "3011683674",
          "1000125025",
          "1825034",
          "1000306431",
          "3006694268",
          "1000306303",
          "3010667733",
          "1828288",
          "3034676720",
          "2919128",
          "3015207155",
          "3000215566",
          "3011500362",
          "3003058448",
          "1526439",
          "3015882686",
          "3025603301",
          "3010287687",
          "3009417901"
        ],
        "device_name": "Component, Traction, Invasive",
        "medical_specialty_description": "Orthopedic",
        "regulation_number": "888.3040",
        "device_class": "2"
      }
    }
  ]
}