NCB® 02.03264.009Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00889024297555), received between May 23, 2019 and Oct 27, 2025 — classified as 6 injuries.

The most frequently reported specific device problem is “Fracture” (6 reports).

2 other recalls cover devices cleared under the same FDA submission (K100111); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryOct 27, 2025Fracture; Fracture

  NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Bone Fracture(s)

  MAUDE report 23394443 ↗
• InjuryJun 18, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL SURGERY WITH A PLATE. SUBSEQUENTLY, HAD SPONTANEOUS RIGHT FEMUR PAIN DUE TO FRACTURE OF AN OSTEOSYNTHESIS PLATE AND FRACTURE OF THE LOWER END OF THE RIGHT FEMUR, FOR THIS REASON, APPROXIMATELY 5 MONTHS POST IMPLANTATION, UNDERWENT A REVISION SURGERY. PLATE WAS REPLACED. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

  Patient problems: Bone Fracture(s); Failure of Implant; Pain

  MAUDE report 22283165 ↗
• InjuryApr 9, 2025Fracture; Fracture

  NO ADDITIONAL EVENT INFORMATION.

  Patient problems: Failure of Implant; Pain

  MAUDE report 21808403 ↗
• InjuryJun 30, 2022Fracture; Fracture

  IT WAS REPORTED THAT A FEMORAL PLATE HAD BEEN IMPLANTED AND APPROXIMATELY 6 MONTHS LATER, DUE TO AN ACCIDENTAL FALL OF THE PATIENT, THE PLATE BROKE TOGETHER WITH A TRANSVERSE BONE FRACTURE, AND REVISION SURGERY WAS REQUIRED. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE, NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Bone Fracture(s); Failure of Implant

  MAUDE report 14873262 ↗
• InjuryAug 16, 2019Fracture; Fracture

  PATIENT WAS IMPLANTED ON THE RIGHT SIDE AND UNDERWENT REVISION SURGERY DUE TO IMPLANT FRACTURE.

  Patient problems: No Information

  MAUDE report 8900427 ↗
• InjuryMay 23, 2019Fracture; Fracture

  IT IS REPORTED THAT PATIENT UNDERWENT AN IMPLANT SURGERY. SUBSEQUENTLY, THE PATIENT HAD A REVISION AS PATIENT FELL ON THE OPERATED LEG RESULTING IN THE FRACTURE OF FEMUR AND FRACTURE OF THE PLATE.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 8635611 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K100111. One submission often covers many models, so check the product and lot details in each record.

• Z-0304-2020 · Oct 10, 2019 · Terminated
  NCB PERIPROSTHETIC, "NCB PP PROX FEM PLATE", Various sizes, Item Nos. 0202263009 0202263012 0202263015 0202263018 0202263021 0202263109 0202263112 0202263115 0202263118 02
• Z-0329-2020 · Oct 10, 2019 · Terminated
  Various temporary devices used during the implantation of the device system: bone fixation plates and screws, drill bits, manual surgical instruments for general use. Item Nos. 020