{
  "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": "219561",
      "product_res_number": "Z-2050-2026",
      "event_date_initiated": "2026-03-20",
      "event_date_posted": "2026-05-01",
      "recall_status": "Open, Classified",
      "res_event_number": "98721",
      "product_code": "MJO",
      "pma_numbers": [
        "P070001",
        "P070001S019",
        "P070001S025"
      ],
      "product_description": "Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5\n\nTotal cervical disc replacement.",
      "code_info": "Model Number: PDSXL5; UDI-DI: 00843193113979; Lot Number: 2026-0026",
      "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": "Jim Kuras\n484-887-8873",
      "reason_for_recall": "Product labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm product was labeled as a 5mm and prodisc C SK U.S. Implant Extra Large 5mm product was labeled as a 6mm.",
      "root_cause_description": "Labeling mix-ups",
      "action": "Centinel Spine notified distributors on about 03/20/2026 via telephone calls and emailed letter.  Surgeons were sent letters via FedEx on 03/24/2026 and by email on 03/25/2026 & 03/26/2026.  Distributors were instructed to identify any affected units on hand, provide photographs documenting such, and arrange for the return of all affected units. Additionally, distributors have been instructed to diligently check prodisc C SK inventory prior to any scheduled surgery to ensure that the recalled lot numbers are not available for implantation. This includes both consignment and loaner inventory. Acknowledgment of the letter has been requested with return envelopes provided. \n\nFor surgeons, they were instructed to monitor any patient(s) that have received the recalled device for any unexpected device-related symptoms throughout the regularly scheduled check-in procedures. \n\nCentinel Spine intends to remove from the market all remaining implants within the lots effected by this recall and issue a replacement product with corrected labeling for any remaining products that are subject to this recall.",
      "product_quantity": "30 units",
      "distribution_pattern": "US Nationwide distribution in the states of AZ, CA, GA, LA, MO, NY, TN, TX.",
      "openfda": {
        "pma_number": [
          "P250042",
          "P060023",
          "P070001",
          "P050010",
          "P120024",
          "P100003",
          "P170036",
          "P090029",
          "P200022",
          "P250028",
          "P110009",
          "P100012",
          "P040006",
          "P060018",
          "P110002"
        ],
        "registration_number": [
          "1000200989",
          "3037407500",
          "3010041430",
          "3015212339",
          "3007494564",
          "1030489",
          "2531195",
          "3004142400",
          "3010363503",
          "1835251",
          "3004774118",
          "1834331",
          "9611813",
          "3014213973",
          "3011461101",
          "3024999441",
          "3009144915",
          "1319660",
          "3007728266",
          "2032098",
          "3005706667",
          "3010057495",
          "3004188066",
          "3010288357",
          "2134285",
          "3009888740",
          "3011521783",
          "3009973336",
          "3013491327",
          "1424434",
          "3010120326",
          "1720929",
          "3003935342",
          "3009417901",
          "3010178296",
          "3025435185",
          "2647346",
          "1833920",
          "1824199",
          "2031966",
          "3013944123",
          "3005061536",
          "1221763",
          "3010120339",
          "1526534",
          "3004788213",
          "3014252644",
          "8044172",
          "1423662",
          "3005144609",
          "3010120135",
          "3013055499",
          "3008812560",
          "9610612",
          "3011277306",
          "3016050940",
          "3030714745",
          "3004072627",
          "1530390",
          "9615674",
          "3018094310",
          "3009973505",
          "3006001176",
          "3012447612",
          "8043792",
          "2133928",
          "2183449",
          "1649518",
          "3006128100",
          "2029275",
          "1721676",
          "1828464",
          "3007017524",
          "3030412764",
          "2219920",
          "3003120897",
          "3016438694"
        ],
        "fei_number": [
          "3002806685",
          "1000200989",
          "3037407500",
          "3002806653",
          "1000136478",
          "1000115656",
          "3010041430",
          "3015212339",
          "3007494564",
          "3004142400",
          "3010363503",
          "1000306340",
          "3014213973",
          "3011461101",
          "3002807479",
          "3024999441",
          "3009144915",
          "1000306431",
          "3007728266",
          "3005706667",
          "3010057495",
          "3004188066",
          "3010288357",
          "3009888740",
          "3011521783",
          "3009973336",
          "3013491327",
          "3010120326",
          "3002795782",
          "1720929",
          "3003935342",
          "3009417901",
          "3025435185",
          "1000477302",
          "2647346",
          "1824199",
          "3013944123",
          "3005061536",
          "1221763",
          "3010120339",
          "1526534",
          "3004788213",
          "3014252644",
          "3005144609",
          "3010120135",
          "3013055499",
          "3001236277",
          "3008812560",
          "3000717902",
          "3002980729",
          "3011277306",
          "3016050940",
          "3030714745",
          "3004072627",
          "3000215103",
          "3018094310",
          "3000215273",
          "3009973505",
          "3006001176",
          "3003058448",
          "3012447612",
          "3008599177",
          "2183449",
          "3006128100",
          "3002808269",
          "3002806315",
          "1721676",
          "1828464",
          "3007017524",
          "3030412764",
          "3002287318",
          "2219920",
          "3003110073",
          "3003120897",
          "3000205591",
          "3000207350",
          "3016438694"
        ],
        "device_name": "Prosthesis, Intervertebral Disc",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}