{
  "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": "Warsaw",
      "state": "IN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "89701",
      "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: US (28 States AL, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, LA, MD, MI, MS, NC, NE, NM, NY, OH, OK, OR, SC, TX, UT, WA, WY), Australia, Japan, and Netherlands",
      "recall_number": "Z-0812-2022",
      "product_description": "BIOMET TRAUMA Drill Bit, Tap, Guide Pin: [DVR Drill Bit, Item # 212000022, DVR 2.2MM DRILL BIT], [ALPS Drill Bit, Item # 214227160, 2.7X160MM CALIBRATED DRILL], [ALPS Drill Bit, Item # 824273100, 4.5X150MM DRILL], [ALPS Drill Bit, Item # 829029170, 2.5X140MM DRILL], [ALPS Drill Bit, Item # 829032170, 3.5X140MM DRILL], [ALPS Tap, Item # 824150170, 3.5X140MM CORTICAL TAP], [ALPS Guide Pin, Item # 829516150, 1.6X150MM BAYONET TIP GUIDE PIN], [ALPS Guide Pin, Item # 829516151, 1.6X150MM THREADED TIP GUIDE PIN]. Instruments are packaged in a vacuum sealed nylon pouch, which is placed in a carton with the appropriate IFU and patient record labels.  Identifying labels on the pouch and the carton.",
      "product_quantity": "2594",
      "reason_for_recall": "Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of sterile barrier integrity. Use of product poses risk of infection, leading to surgical intervention, and/or extension of surgery to find another part.",
      "recall_initiation_date": "20220214",
      "center_classification_date": "20220318",
      "termination_date": "20240930",
      "report_date": "20220330",
      "code_info": "44 lots: Lot #, UDI # -  [014490, (01)00887868447037(17)310608(10)014490],  [014500, (01)00887868447068(17)310608(10)014500],  [014520, (01)00887868447068(17)310610(10)014520],  [084850, (01)00887868447006(17)310621(10)084850],  [084860, (01)00887868447006(17)310623(10)084860],  [084870, (01)00887868447006(17)310623(10)084870],  [084880, (01)00887868447006(17)310624(10)084880],  [102920, (01)00887868447006(17)310630(10)102920],  [102930, (01)00887868447006(17)310716(10)102930],  [102940, (01)00887868447006(17)310729(10)102940],  [102950, (01)00887868447006(17)310729(10)102950],  [102960, (01)00887868447006(17)310728(10)102960],  [103120, (01)00887868447006(17)310728(10)103120],  [119750, (01)00887868446054(17)310624(10)119750],  [119760, (01)00887868446054(17)310624(10)119760],  [120800, (01)00887868446054(17)310630(10)120800],  [120810, (01)00887868446054(17)310713(10)120810],  [204700, (01)00887868447006(17)310714(10)204700],  [205750, (01)00887868447006(17)310714(10)205750],  [331580, (01)00887868446054(17)310803(10)331580],  [331590, (01)00887868446054(17)310723(10)331590],  [331600, (01)00887868446054(17)310726(10)331600],  [386440, (01)00887868447105(17)310809(10)386440],  [391450, (01)00887868446054(17)310816(10)391450],  [391470, (01)00887868447068(17)310811(10)391470],  [391660, (01)00887868447068(17)310811(10)391660],  [391670, (01)00887868447075(17)310811(10)391670],  [416500, (01)00887868446054(17)310817(10)416500],  [416510, (01)00887868446054(17)310817(10)416510],  [416520, (01)00887868446054(17)310819(10)416520],  [416640, (01)00887868446054(17)310823(10)416640],  [492660, (01)00887868447006(17)310722(10)492660],  [534680, (01)00887868446948(17)310713(10)534680],  [534690, (01)00887868446948(17)310713(10)534690],  [534700, (01)00887868446948(17)310812(10)534700],  [610840, (01)00887868446948(17)310915(10)610840],  [806490, (01)00887868447075(17)310528(10)806490],  [820340, (01)00887868447006(17)310618(10)820340],  [834950, (01)00887868446733(17)311101(10)834950],  [836360, (01)00887868446948(17)310119(10)836360],  [896640, (01)00887868446733(17)311101(10)896640],  [896660, (01)00887868446733(17)311027(10)896660],  [939270, (01)00887868447068(17)310601(10)939270],  [964360, (01)00887868447068(17)310603(10)964360]"
    }
  ]
}