{
  "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": "2026-09-05",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 3
    }
  },
  "results": [
    {
      "cfres_id": "218601",
      "product_res_number": "Z-1554-2026",
      "event_date_initiated": "2026-02-06",
      "event_date_posted": "2026-03-11",
      "recall_status": "Open, Classified",
      "res_event_number": "98399",
      "product_code": "OWW",
      "k_numbers": [
        "K200503",
        "K230316"
      ],
      "product_description": "Artelon  FlexBand Dynamic Matrix\nRef: 31057",
      "code_info": "A10011001/GTIN: 00850003396019",
      "firm_fei_number": "3010673515",
      "recalling_firm": "International Life Sciences",
      "address_1": "8601 Dunwoody Pl Ste 250 8601 Dunwoody Pl",
      "address_2": "Ste 250",
      "city": "Atlanta",
      "state": "GA",
      "postal_code": "30350-2513",
      "additional_info_contact": "Dannielle Stap\n901-598-8510",
      "reason_for_recall": "Augmentation devices failed bacterial endotoxin testing.",
      "root_cause_description": "Process control",
      "action": "On February 6, 2026, International Life Science ( subsidiary of Stryker) issued a Urgent: Medical Device Recall notification to affected consignees. International Life Science asked consignees to take the following actions:\n\n1.\tImmediately check your internal inventory to locate the product, remove them from their point of use, and isolate/quarantine the unit(s) to prevent accidental use.\n2.\tReview the product issue and risks as communicated  and communicate the issue as appropriate in your organization.\n3.\tReturn the enclosed business reply form by email\na.\tResponse is required, even if you may not have any physical inventory on site anymore. \n4.\tUpon receipt of the completed business reply form, Stryker will contact you to arrange for the return of your product(s).\n5.\tMaintain awareness of this communication internally until required actions have been completed within your facility.\n6.\tIf you have further distributed the affected product, please notify the applicable parties.\na.\tIf possible, inform us if any of the subject devices have been distributed to other organizations, including contact details, so that we can inform the recipients appropriately.\nb.\tIf you are a distributor, note that you are responsible for notifying your affected customers.",
      "distribution_pattern": "Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NY, OH, OK, \tOR, PA, SD, TN, TX, UT, VA, WA, WI, WY and the countries of Australia, France, Germany, Italy, Japan, Korea, Spain, Switzerland, United Kingdom, United Arab Emirates, Slovenia.",
      "openfda": {
        "k_number": [
          "K230316",
          "K121216",
          "K250021",
          "K222220",
          "K241906",
          "K242187",
          "K203267",
          "K251655",
          "K240817",
          "K160364"
        ],
        "registration_number": [
          "3010673515",
          "8043792",
          "3012669262",
          "3019101334",
          "1017294",
          "3000215346",
          "3033302333",
          "3027699572",
          "9614442",
          "3009493875",
          "2030598",
          "1320894",
          "1721676",
          "3014527904",
          "3033273526",
          "1064858"
        ],
        "fei_number": [
          "3010673515",
          "3012669262",
          "3019101334",
          "1017294",
          "3000215346",
          "1000518731",
          "3033302333",
          "3009493875",
          "3002808269",
          "3027699572",
          "3014527904",
          "1721676",
          "3000303710",
          "3033273526",
          "3008397795",
          "3001451571"
        ],
        "device_name": "Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon",
        "medical_specialty_description": "General, Plastic Surgery",
        "regulation_number": "878.3300",
        "device_class": "2"
      }
    }
  ]
}