{
  "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": 2
    }
  },
  "results": [
    {
      "cfres_id": "220560",
      "product_res_number": "Z-2897-2026",
      "event_date_initiated": "2026-03-19",
      "event_date_posted": "2026-08-06",
      "recall_status": "Open, Classified",
      "res_event_number": "99025",
      "product_code": "LWH",
      "product_description": "Brand Name: U2 Total Knee System\nProduct Name: Femoral offset bushing, 0mm and 4mm\nModel/Catalog Number: 9323-5310\nSoftware Version: N/A\nProduct Description: Manual Orthopedic Surgical Instrument\nComponent: No, N/A",
      "code_info": "Lot Code: Product Number 9323-5310; UDI-DI 04719886908060; Lot number 25FC58",
      "firm_fei_number": "1000395711",
      "recalling_firm": "United Orthopedic Corp.",
      "address_1": "No. 16 Luke 1st Rd.",
      "city": "Kaohsiung",
      "state": "Luzhu Dist.",
      "country": "Taiwan",
      "additional_info_contact": "Mr. Calvin Lin\n+886-22-9294567",
      "reason_for_recall": "Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant.",
      "root_cause_description": "Device Design",
      "action": "On 03/09/2026, the firm distributed an \"URGENT: MEDICAL DEVICE RECALL\" Letter informing customer that due the fact that the Femoral offset bushing in the affected devices is engraved with the incorrect numbering, and the rotational direction does not align with the intended orientation. \n\nCustomers are instructed to:\n1. Examine inventory immediately to locate the affected product whose quantities and lot numbers are listed in the letter.  Note the product may have already been returned.\n2. Cease all use of these devices immediately and quarantine all affected devices in their territory for immediate return.\n3.\tCustomer Service will be contacting customers regarding replacements. If customers still have the product,  they are requested to immediately return the affected product using the prepaid airbills on RMA XXXX . \na. Write the RMA number on the outside of the box clearly and legibly. \nb. Ship recalled product via Fed Ex standard overnight to:\nUOC USA INC.\nAttention: RMA# XXXX\n16601 Hale Ave.  Irvine, CA 92606\n(Attached Shipping Label)\n4. Additionally, if customers has further distributed the recall product, please provide that customer with a copy of this recall notification and assist them with the return of the product.\n5. Complete and return the following page according to the instructions.\n\nFor questions - contact UOC Sr. Director of Sales Operations at 949.328.3366.",
      "product_quantity": "3",
      "distribution_pattern": "US Nationwide distribution in the states of Texas and Michigan.",
      "openfda": {
        "k_number": [
          "K120473",
          "K873555",
          "K093557",
          "K982260",
          "K912824",
          "K060076",
          "K100551",
          "K073180",
          "K062642",
          "K945144",
          "K972302",
          "K121274",
          "K790538",
          "K061316",
          "K071355"
        ],
        "registration_number": [
          "3032960221",
          "3015967359",
          "3011120183",
          "3008879776",
          "3005210579",
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          "3007305426",
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        "fei_number": [
          "3032960221",
          "3015967359",
          "1000306431",
          "3011120183",
          "3008879776",
          "3005210579",
          "3000183921",
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          "1043214",
          "1000112968",
          "3006847952",
          "3017309443",
          "1000112877",
          "3012494290",
          "3007407626",
          "1417592",
          "3014926389",
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          "3016734231",
          "3005524530",
          "3009542933",
          "3005160949",
          "3002821504",
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          "3002677549",
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          "1043572",
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          "3007773213",
          "3000204953",
          "3019315696",
          "3010453313",
          "3010305275",
          "3014421917",
          "3032171543",
          "3001236905",
          "3015058854",
          "3004496839",
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          "3005841027",
          "1921846",
          "3006487092",
          "1030451",
          "3017270814",
          "3045058049"
        ],
        "device_name": "Counter, Sponge, Surgical",
        "medical_specialty_description": "General Hospital",
        "regulation_number": "880.2740",
        "device_class": "1"
      }
    }
  ]
}