{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Warsaw",
      "state": "IN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "73140",
      "recalling_firm": "Biomet, Inc.",
      "address_1": "56 E Bell Dr",
      "address_2": "N/A",
      "postal_code": "46582-6989",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution: US (Nationwide) and countries of: Panama; Korea; Japan; Netherlands; Ecuador; Chile; Canada; and Australia.",
      "recall_number": "Z-1082-2016",
      "product_description": "Crosslock DVR ePAK -Sterile, Ref 81180050, are complete surgical sets including plates, screws, and instruments for orthopedic fixation    The Cross lock DVR ePAK Volar Rim Plates system is intended for fixation of fractures, mal unions, and osteotomies involving the distal radius. The DVR Wrist ePAK system is intended stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstructions of small bones of the hand, foot, radius, ulna, ankle, humerus, scapula and pelvis, particularly in osteopenic bone.",
      "product_quantity": "21,268",
      "reason_for_recall": "Components of the DVR ePAKs can oxidize during shipment and storage prior to use.  A delay in surgery, less than 30 minutes, may occur if the surgical staff proceeds to re-sterilize the product.   If oxidative material would flake off a component contained within the ePAK and enter the surgical field/wound an inflammatory reaction may occur. The inflammatory reaction may result in a foreign body reaction and/or metal hypersensitivity.  Oxidized components have failed cytotoxicity testing.",
      "recall_initiation_date": "20160129",
      "center_classification_date": "20160308",
      "termination_date": "20170905",
      "report_date": "20160316",
      "code_info": "All Lots.    Part number:                    Description:   811810050  DVR EPAK EX NRW LOCK PLT RIGHT  811811040  DVR EPAK NRW MINI LOCK PLT R  811811050  DVR EPAK NRW LOCK PLT R  811812040  DVR EPAK MINI LOCK PLT R  811812050  DVR EPAK DIST VLR PT STD R  811812060  DVR EPAK DISTAL VLR PLT MED RT  811812090  DVR EPAK DISTAL PLT LONG RT  811812125  DVR EPAK EXT LONG LOCK PLT R  811812175  DVR EPAK EX-EXT LONG LK PLT R  811813050  DVR EPAK WIDE LOCK PLT R  811814050  DVR EPAK VOLAR RIM PLATE RIGHT  811815050  DVR EPAK VOLAR RIM NRW PLT RT  811817050  DVR EPAK DORSAL PLATE STD RT  811817150  DVR EPAK DORSAL PLATE WIDE RT  811818060  DVR EPAK RADIAL PLT STD RIGHT  811818160  DVR EPAK RADIAL PLATE WIDE RT  811820050  DVR EPAK EX NRW LOCK PLT LEFT  811821040  DVR EPAK NRW MINI LOCK PLT L  811821050  DVR EPAK NRW LOCK PLT L  811822040  DVR EPAK MINI LOCK PLT L  811822050  DVR EPAK LOCK PLT L  811822060  DVR EPAK MEDIUM LOCK PLT L  811822090  DVR EPAK LONG LOCK PLT L  811822125  DVR EPAK EXT LONG LOCK PLT L  811822175  DVR EPAK EX-EXT LONG LK PLT L  811823050  DVR EPAK WIDE LOCK PLT L  811824050  DVR EPAK VOLAR RIM PLATE LEFT  811825050  DVR EPAK VOLAR RIM NRW PLT LT  811827050  DVR EPAK DORSAL PLATE STD LEFT  811827150  DVR EPAK DORSAL PLATE WIDE LT  811828060  DVR EPAK RADIAL PLATE STD LEFT  811828160  DVR EPAK RADIAL PLATE WIDE LT  811839050  DVR EPAK ULNA PLATE BILATERAL  811899001  DVR EPAK RIGHT DNI  811899002  DVR EPAK LEFT DNI  811899003  EPAK DVR C/LCK VOLR RIM RT DNI  811899004  EPAK DVR C/LCK VOLR RIM LT DNI  811899005  EPAK DVR DORSAL PLATE RT DNI  811899006  EPAK DVR DORSAL PLATE LT DNI  811899007  EPAK DVR RDL COLUMN PLT RT DNI  811899008  EPAK DVR RDL COLUMN PLT LT DNI  811899009  EPAK DVR ULNA PLT BILAT DNI  811911050  DVR EPAK NRW LOCK PEG RT  811912050  DVR EPAK LOCK PEG RT  811913050  DVR EPAK WIDE LOCK PEG RT  811921050  DVR EPAK NRW LOCK PEG LT  811922050  DVR EPAK LOCK PEG LT  811923050  DVR EPAK WIDE LOCK PEG LT  811999001  DVR EPAK PEG RIGHT DNI  811999002  DVR EPAK PEG LEFT DNI"
    }
  ]
}