{
  "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": 1
    }
  },
  "results": [
    {
      "cfres_id": "161212",
      "product_res_number": "Z-0974-2018",
      "event_date_initiated": "2018-01-25",
      "event_date_created": "2018-03-12",
      "recall_status": "Open, Classified",
      "res_event_number": "79030",
      "product_code": "OLC",
      "product_description": "CMI (Collagen Meniscus Implant) device, Ivy Sports Medicine s collagen-based meniscus implant\n\nProduct Usage:\nThe CMI device, Ivy Sports Medicine s collagen-based meniscus implant, is comprised primarily of bovine type I collagen (nominally 99%) derived from tendon and small quantities of glycosaminoglycans (GAGs: chondroitin sulfate and sodium hyaluronate). The device functions as a resorbable scaffold that is replaced by the patient s own tissue.The CMI device is designed to function as an absorbable template to facilitate host meniscus tissue regeneration in patients who have an irreparable meniscus tear or loss of meniscus tissue. The CMI meniscus tissue through the implant s absorption and replacement by patient s native tissue.",
      "code_info": "Serial/Lot Number(s) Affected: 4600: 15J456; 4601: 16A463, 16G470, 17F510; 4607: 16A461, 16D465, 16E467, 16F468, 17E506, 17E507; 4612: 16A458, 16A459, 17D489, 17E503, 17E504",
      "firm_fei_number": "2936485",
      "recalling_firm": "Stryker Corporation",
      "address_1": "5900 Optical Ct",
      "city": "San Jose",
      "state": "CA",
      "postal_code": "95138-1400",
      "reason_for_recall": "The recalled products were shipped without the required temperature control packaging, therefore could potentially have been exposed to elevated temperatures during transit.",
      "root_cause_description": "Packaging",
      "action": "The international Stryker site was notified by email on 1/25/2018. Customers are instructed to: 1. Inform individuals within your organization who need to be aware of this device removal. 2. Review Part Numbers (4600, 4601, 4607, and 4612) for affected lot numbers. Please determine if you have the\naffected product in stock. Response is required. 3. If no product is found, notify your local Stryker office.4. If you do have product, segregate the product and call your local Stryker office to arrange for product return and\nissuance of credit.",
      "product_quantity": "155 devices",
      "distribution_pattern": "Netherlands",
      "openfda": {
        "k_number": [
          "K082079",
          "K242302",
          "K170364"
        ],
        "registration_number": [
          "2936485",
          "3003300673",
          "3027448274",
          "3013820501",
          "2245304",
          "2249852"
        ],
        "fei_number": [
          "2936485",
          "3003300673",
          "3027448274",
          "3013820501",
          "2245304",
          "3008817245"
        ],
        "device_name": "Scaffold, Partial Medial Meniscal Defects Extending Into The Red/White Zone, Resorbable Bovine Collagen",
        "medical_specialty_description": "General, Plastic Surgery",
        "regulation_number": "878.3300",
        "device_class": "2"
      }
    }
  ]
}