{
  "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,
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    }
  },
  "results": [
    {
      "cfres_id": "218137",
      "product_res_number": "Z-1426-2026",
      "event_date_initiated": "2025-12-31",
      "event_date_posted": "2026-02-17",
      "recall_status": "Open, Classified",
      "res_event_number": "98282",
      "product_code": "MJO",
      "pma_numbers": [
        "P070001",
        "P070001S019",
        "P070001S025"
      ],
      "product_description": "Brand Name: Prodisc\nProduct Name: Prodisc C SK\nModel/Catalog Number: PDSL6\nSoftware Version: N/A\nProduct Description: Total cervical disc replacement\nComponent: No",
      "code_info": "Model Number: PDSL6; \nUDI-DI 00843193113924; \nLot 2025-0776;",
      "firm_fei_number": "3007494564",
      "recalling_firm": "Centinel Spine, Inc.",
      "address_1": "900 Airport Rd Ste 3b 900 Airport Rd",
      "address_2": "Ste 3b",
      "city": "West Chester",
      "state": "PA",
      "postal_code": "19380-3416",
      "additional_info_contact": "888-736-2724",
      "reason_for_recall": "Products were mislabeled as the 6mm product but included the 5 mm product.",
      "root_cause_description": "Process control",
      "action": "On or around December 31, 2025 Phone calls were made to customers to notify them of the recall. Follow-up URGENT PRODISC C SK US IMPLANT LARGE 6MM DEVICE RECALL letters were also emailed to customers.\nActions to be taken: We request that you review your inventory and return any units in your possession of this impacted lot number. We recommend monitoring any patient that has received the recalled device for any unexpected device-related symptoms throughout the regularly scheduled check-in procedures.\nActions to Be Taken by Centinel Spine: Centinel Spine intends to remove all remaining implants effected by this recall from the market and issue a replacement product with corrected labeling for any remaining products in the Distributors possession that are subject to this recall.",
      "product_quantity": "20 units",
      "distribution_pattern": "US Nationwide distribution in the states of AL, CA, CO, LA, NY, OR, TN, TX.",
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        ],
        "device_name": "Prosthesis, Intervertebral Disc",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}