NCB® 02.02264.012Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00889024292840), received between Dec 19, 2018 and Sep 9, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Fracture” (4 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 16, 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.

• InjurySep 9, 2024Separation Problem; Separation Problem

  DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 20174135 ↗
• InjurySep 29, 2020Fracture; Fracture

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

  Patient problems: Failure of Implant

  MAUDE report 10598822 ↗
• InjurySep 7, 2020Fracture; Fracture

  PATIENT WAS IMPLANTED ON THE UNKNOWN SIDE AND UNDERWENT REVISION SURGERY DUE TO IMPLANT FRACTURE. FROM THE IMPLANTATION REPORT, THE PATIENT'S ANATOMY AND PRIOR SURGERIES/ BONE QUALITY MAY HAVE BEEN A CONTRIBUTING FACTOR. THE SURGEON ASKED THAT THE PRODUCT BE SENT TO ROYAL PERTH HOSPITAL WHERE THEY WILL INVESTIGATE FURTHER. THIS IS THE STANDARD PROCESS FOR A LOT OF IMPLANTS REMOVED DURING REVISIONS IN PERTH (PRODUCT WONT BE AVAILABLE).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10499295 ↗
• InjuryAug 10, 2020Fracture; Fracture

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

  Patient problems: Bone Fracture(s); No Known Impact Or Consequence To Patient

  MAUDE report 10383449 ↗
• InjuryDec 19, 2018Fracture; Fracture

  PATIENT WAS IMPLANTED ON UNKNOWN SIDE AND UNDERWENT REVISION DUE TO IMPLANT FRACTURE.

  Patient problems: No Information

  MAUDE report 8177937 ↗

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-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
• 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 0202263121