{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "141084",
      "product_res_number": "Z-0162-2016",
      "event_date_initiated": "2015-09-23",
      "event_date_posted": "2015-10-23",
      "recall_status": "Terminated",
      "event_date_terminated": "2016-02-12",
      "res_event_number": "72425",
      "product_code": "OSF",
      "k_numbers": [
        "K102795"
      ],
      "product_description": "Signature Patient-Specific Surgical Guides; patient specific instruments used as a guide during surgical procedure for total and partial knee arthroplasty. Part of the Signature Personalized Patient Care System.",
      "code_info": "42422461: Signature SIG CT/TI(A Guides 04-05 Slidex Distal-MP/Premier Tibial & 42422551 : Signature TKA GDE/MDL SET 03-05 MP/Premier Distal- MP/Premier Tibial  42422461 139540 2016-02-17  42-422551 1 391 51 2016-01-14  42422551 1 38805 2016-02-03  42-422551 140787 2016-03-03",
      "firm_fei_number": "3003998208",
      "recalling_firm": "Materialise N.V.",
      "address_1": "15 Technologielaan",
      "city": "Heverlee",
      "country": "Belgium",
      "additional_info_contact": "Lisa Kamischke\n724-259-7033",
      "reason_for_recall": "Potential inaccuracies in the alignment of the guides.  Surgery was inaccurately planned because the patient image data was incorrectly processed.",
      "root_cause_description": "Use error",
      "action": "On September 16, 2015 Materialise NV identified four cases where not all available image sets were used to design the case. On September 18, 2015, prior to the surgery dates Materialise informed (phone call) the Signature\r\nServices Manager of Zimmer Biomet that inaccuracies in the alignment of the knee might be observed with the use of the guides due to this issue. Biomet was asked to segregate the packages for these four cases and to return them to the Materialise US office. On September 23, 2015 this was\r\nfollowed up by e-mail notification letter with response forms.\r\nBiomet was requested to contact Materialise customer service to return these four cases and arrange a replacement set of patient specific surgical guides Monday through Friday, 8:00 AM to 4:30 PM, Eastern Time. E-mail : ortho-quality@materialise. be\r\nCustomer Service\r\nMaterialise USA LLC\r\n44650 Helm Court\r\nPlymouth, Michigan 48170\r\n734-259-7033",
      "product_quantity": "4",
      "distribution_pattern": "Distributed in MI, ID, TX, and in France.",
      "openfda": {
        "k_number": [
          "K200384",
          "K093491",
          "K233315"
        ],
        "registration_number": [
          "3008869747",
          "3016676864"
        ],
        "fei_number": [
          "3008869747",
          "3016676864"
        ],
        "device_name": "Patient Specific Manual Orthopedic Stereotaxic System",
        "medical_specialty_description": "Neurology",
        "regulation_number": "882.4560",
        "device_class": "2"
      }
    }
  ]
}