{
  "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": "2026-09-10",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "217513",
      "product_res_number": "Z-0911-2026",
      "event_date_initiated": "2025-11-11",
      "event_date_posted": "2025-12-11",
      "recall_status": "Open, Classified",
      "res_event_number": "98056",
      "product_code": "NWN",
      "product_description": "DEXLOCK Achilles Repair Implant Kits, MAKT4520",
      "code_info": "Lot 19019\nUDI-DI 10193489131703",
      "firm_fei_number": "1417592",
      "recalling_firm": "Medline Industries, LP",
      "address_1": "3 Lakes Dr",
      "city": "Northfield",
      "state": "IL",
      "postal_code": "60093-2753",
      "additional_info_contact": "Haley Barclay\n866-359-1704",
      "reason_for_recall": "There have been multiple complaints of drill bit fusing to the bushing/sleeve within the drill guide during use. Retrieving a replacement drill bit and drill guide may prolong the surgical procedure.",
      "root_cause_description": "Under Investigation by firm",
      "action": "Firm began notifying consignees on 11/11/2025 via Urgent Medical Device Recall letters.\n\nCustomers have been instructed to over-label kits with a sticker instructing them to not use the drill guide within the Achilles Kit and to use the reusable 3.6mm drill guide from the Soft Tissue Instrument Tray. Customers who do not have a Soft Tissue Instrument Tray have been instructed to notify Medline so that a tray can be provided.\n\nCustomers were instructed to quarantine all affected product in stock and return a completed response form to Medline. Upon receipt of the response form, the firm will then provide over-labels to place on affected inventory.\n\nIf you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.",
      "product_quantity": "163 US",
      "distribution_pattern": "US Nationwide distribution in the states of AL, AR, AZ, CO, DE, FL, GA, ID, IL, IN, KS, KY, LA, MA, MT, NC, NJ, OH, OK, PA, SC, TX, VA, WI.",
      "openfda": {
        "registration_number": [
          "3004111573",
          "9616088",
          "3010052483",
          "1423537",
          "1417592",
          "3007329020",
          "1061124"
        ],
        "fei_number": [
          "3002902735",
          "3004111573",
          "1000512168",
          "3010052483",
          "3001236905",
          "1417592",
          "3007329020"
        ],
        "device_name": "Laparoscopic Bone Anchor Urethropexy Instrument Kit",
        "medical_specialty_description": "Orthopedic",
        "regulation_number": "888.3040",
        "device_class": "2"
      }
    }
  ]
}