{
  "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": "2026-09-02",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 3
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Gainesville",
      "state": "FL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "96102",
      "recalling_firm": "Exactech, Inc.",
      "address_1": "2320 Nw 66th Ct",
      "address_2": "",
      "postal_code": "32653-1630",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "U.S.: AR, CA, CO, FL, GA, HI, IL, IN, KS, KY, LA, MD, MN, NV, NY, OH, OK, PR,SC, TN, TX and VA  O.U.S.: Argentina, Colombia, Germany, Guatemala, Japan and Spain",
      "recall_number": "Z-1165-2025",
      "product_description": "AcuMatch XLE  Item Number / Product Description:  140-28-27\tAM EHXL 0¿ LNR G 28MM  140-32-27\tAM EHXL 0¿ LNR G 32MM  140-32-28\tAM EHXL 0¿ LNR H 32MM  140-28-29\tAM EHXL 0¿ LNR J 28MM  140-32-29\tAM EHXL 0¿ LNR J 32MM  140-36-29\tAM EHXL 0¿ LNR J 36MM  140-32-30\tAM EHXL 0¿ LNR K 32MM  140-36-30\tAM EHXL 0¿ LNR K 36MM  140-28-25\tAM EHXL 0¿LNR E 28MM  140-28-26\tAM EHXL 0¿LNR F 28MM  140-28-28\tAM EHXL 0¿LNR H 28MM  140-36-28\tAM EHXL 0¿LNR H 36MM  140-28-30\tAM EHXL 0¿LNR K 28MM  142-28-24\tAM EHXL 15¿ LNR D 28MM  142-28-26\tAM EHXL 15¿ LNR F 28MM  142-32-27\tAM EHXL 15¿ LNR G 32MM  142-32-28\tAM EHXL 15¿ LNR H 32MM  142-36-28\tAM EHXL 15¿ LNR H 36MM  142-36-29\tAM EHXL 15¿ LNR J 26MM  142-28-29\tAM EHXL 15¿ LNR J 28MM  142-32-29\tAM EHXL 15¿ LNR J 32MM  142-28-30\tAM EHXL 15¿ LNR K 28MM  142-32-30\tAM EHXL 15¿ LNR K 32MM  142-36-30\tAM EHXL 15¿ LNR K 36MM  142-28-25\tAM EHXL 15¿LNR E 28MM  142-28-27\tAM EHXL 15¿LNR G 28MM  142-28-28\tAM EHXL 15¿LNR H 28MM  144-28-28\tAM EHXL EXT LNR H 28MM  144-28-29\tAM EHXL EXT LNR J 28MM  144-28-25\tAM EHXL EXTLNR E 28MM  144-28-26\tAM EHXL EXTLNR F 28MM  144-28-27\tAM EHXL EXTLNR G 28MM  144-28-30\tAM EHXL EXTLNR K 28MM  148-28-26\tAM EHXL LAT LNR F 28MM  148-28-27\tAM EHXL LAT LNR G 28MM  148-36-28\tAM EHXL LAT LNR H 36MM  148-36-29\tAM EHXL LAT LNR J 36MM  148-28-30\tAM EHXL LAT LNR K 28MM  148-36-30\tAM EHXL LAT LNR K 36MM  148-28-25\tAM EHXL LATLNR E 28MM  148-28-28\tAM EHXL LATLNR H 28MM  148-28-29\tAM EHXL LATLNR J 28MM    All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment.",
      "product_quantity": "42",
      "reason_for_recall": "Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer.",
      "recall_initiation_date": "20241231",
      "center_classification_date": "20250212",
      "report_date": "20250219",
      "code_info": "Item Number / Product Description/ UDI-DI code: 140-28-27 AM EHXL 0¿ LNR G 28MM 10885862537997 140-32-27 AM EHXL 0¿ LNR G 32MM 10885862538031 140-32-28 AM EHXL 0¿ LNR H 32MM 10885862538048 140-28-29 AM EHXL 0¿ LNR J 28MM 10885862538017 140-32-29 AM EHXL 0¿ LNR J 32MM 10885862538055 140-36-29 AM EHXL 0¿ LNR J 36MM 10885862538086 140-32-30 AM EHXL 0¿ LNR K 32MM 10885862538062 140-36-30 AM EHXL 0¿ LNR K 36MM 10885862538093 140-28-25 AM EHXL 0¿LNR E 28MM 10885862537973 140-28-26 AM EHXL 0¿LNR F 28MM 10885862537980 140-28-28 AM EHXL 0¿LNR H 28MM 10885862538000 140-36-28 AM EHXL 0¿LNR H 36MM 10885862538079 140-28-30 AM EHXL 0¿LNR K 28MM 10885862538024 142-28-24 AM EHXL 15¿ LNR D 28MM 10885862538123 142-28-26 AM EHXL 15¿ LNR F 28MM 10885862538147 142-32-27 AM EHXL 15¿ LNR G 32MM 10885862538192 142-32-28 AM EHXL 15¿ LNR H 32MM 10885862538208 142-36-28 AM EHXL 15¿ LNR H 36MM 10885862538239 142-36-29 AM EHXL 15¿ LNR J 26MM 10885862538246 142-28-29 AM EHXL 15¿ LNR J 28MM 10885862538178 142-32-29 AM EHXL 15¿ LNR J 32MM 10885862538215 142-28-30 AM EHXL 15¿ LNR K 28MM 10885862538185 142-32-30 AM EHXL 15¿ LNR K 32MM 10885862538222 142-36-30 AM EHXL 15¿ LNR K 36MM 10885862538253 142-28-25 AM EHXL 15¿LNR E 28MM 10885862538130 142-28-27 AM EHXL 15¿LNR G 28MM 10885862538154 142-28-28 AM EHXL 15¿LNR H 28MM 10885862538161 144-28-28 AM EHXL EXT LNR H 28MM 10885862538291 144-28-29 AM EHXL EXT LNR J 28MM 10885862538307 144-28-25 AM EHXL EXTLNR E 28MM 10885862538260 144-28-26 AM EHXL EXTLNR F 28MM 10885862538277 144-28-27 AM EHXL EXTLNR G 28MM 10885862538284 144-28-30 AM EHXL EXTLNR K 28MM 10885862538314 148-28-26 AM EHXL LAT LNR F 28MM 10885862538338 148-28-27 AM EHXL LAT LNR G 28MM 10885862538345 148-36-28 AM EHXL LAT LNR H 36MM 10885862538383 148-36-29 AM EHXL LAT LNR J 36MM 10885862538390 148-28-30 AM EHXL LAT LNR K 28MM 10885862538376 148-36-30 AM EHXL LAT LNR K 36MM 10885862538406 148-28-25 AM EHXL LATLNR E 28MM 10885862538321 148-28-28 AM EHXL LATLNR H 28MM 10885862538352 148-28-29 AM EHXL LATLNR J 28MM 10885862538369",
      "more_code_info": ""
    }
  ]
}