{
  "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": "72741",
      "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": "AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, PR  CHILE, COSTA RICA, NETHERLANDS, CANADA",
      "recall_number": "Z-0450-2016",
      "product_description": "A.L.P.S. 4.0mm Cancellous Locking Screws   intended for use in stabilization and fixation of fractures, revision procedures, fusions, reconstructions (osteotomy) and non-unions of the bones.",
      "product_quantity": "182, 965",
      "reason_for_recall": "These screws have a single lead (instead of a triple lead) thread.  The screw may sit proud in the plate, If the screw does not lock into the plate; the screw may back out. If the screw sits proud, soft tissue irritation may occur. If the screw does not lock into the plate and backs out, a revision surgery may be necessary.",
      "recall_initiation_date": "20151120",
      "center_classification_date": "20151218",
      "termination_date": "20160908",
      "report_date": "20151230",
      "code_info": "Part number and size (non-sterile)  816140010, 4.0X10MM;  816140012, 4.0X12MM;  816140014, 4.0X14MM;  816140016, 4.0X16MM;  816140018, 4.0X18MM;  816140020, 4.0X20MM;  816140022, 4.0X22MM;  816140024, 4.0X24MM;  816140026, 4.0X26MM;  816140028, 4.0X28MM;  816140030, 4.0X30MM;  816140032, 4.0X32MM;  816140034, 4.0X34MM;  816140036, 4.0X36MM;  816140038, 4.0X38MM;  816140040, 4.0X40MM;  816140042, 4.0X42MM;  816140044, 4.0X44MM;  816140046, 4.0X46MM;  816140048, 4.0X48MM;  816140050, 4.0X50MM;  816140055, 4.0X55MM;  816140060, 4.0X60MM;  816140065, 4.0X65MM;  816140070, 4.0X70MM;  816140075, 4.0X75MM;  816140080, 4.0X80MM;  816140085, 4.0X85MM;  816140090, 4.0X90MM;  816140095, 4.0X95MM;  816140100, 4.0X100MM    Part number and size (sterile)  856140010, 4.0X10MM;  856140012, 4.0X12MM;  856140014, 4.0X14MM;  856140016, 4.0X16MM;  856140018, 4.0X18MM;  856140020, 4.0X20MM;  856140022, 4.0X22MM;  856140024, 4.0X24MM;  856140026, 4.0X26MM;  856140028, 4.0X28MM;  856140030, 4.0X30MM;  856140032, 4.0X32MM;  856140034, 4.0X34MM;  856140036, 4.0X36MM;  856140038, 4.0X38MM;  856140040, 4.0X40MM;  856140042, 4.0X42MM;  856140044, 4.0X44MM;  856140046, 4.0X46MM;  856140048, 4.0X48MM;  856140050, 4.0X50MM;  856140055, 4.0X55MM;  856140060, 4.0X60MM;  856140065, 4.0X65MM;  856140070, 4.0X70MM.  All lots manufactured between 06/01/08 and 06/01/15."
    }
  ]
}