NCB® 02.02264.018Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00889024292864), received between Dec 21, 2020 and Aug 19, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Fracture” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryAug 19, 2025Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT AN INITIAL PROCEDURE. SUBSEQUENTLY, THE PATIENT SUSTAINED A BONE FRACTURE AND WAS REVISED APPROXIMATELY 10 WEEKS POST-IMPLANTATION. NO ADDITIONAL INTRA-OPERATIVE FINDINGS, DEVICE MALFUNCTION, OR ENVIRONMENTAL CONDITIONS WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Bone Fracture(s); Insufficient Information

  MAUDE report 22839819 ↗
• InjuryMar 14, 2024Fracture; Fracture

  IT WAS REPORTED THAT A PATIENT HAD A REVISION SURGERY DUE TO NCB PERIPROSTHETIC FEMUR PLATE FRACTURE, APPROXIMATELY 4 MONTHS AFTER IMPLANTATION. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Failure of Implant

  MAUDE report 18905995 ↗
• InjuryAug 8, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT REQUIRED REVISION SURGERY DUE TO A FRACTURED FEMUR PLATE IMPLANT. THE FRACTURED PLATE WAS REMOVED AND REPLACED. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 17478036 ↗
• InjuryJun 5, 2023Fracture; Fracture

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

  Patient problems: Failure of Implant

  MAUDE report 17058745 ↗
• InjuryDec 21, 2020Fracture; Fracture

  NO CHANGE TO PREVIOUSLY REPORTED EVENT.

  Patient problems: Failure of Implant

  MAUDE report 11045659 ↗

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