NCB® 02.02263.018Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00889024292710), received between Dec 18, 2018 and Feb 10, 2026 — classified as 9 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 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 10, 2026Fracture

  IT WAS REPORTED THE PATIENT UNDERWENT PRIMARY SURGERY, AND SUBSEQUENTLY WAS REVISED DUE TO A NCB PLATE FRACTURE APPROXIMATELY 8 WEEKS POST PRIMARY SURGERY. A NEW PLATE WAS IMPLANTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Nonunion/Delayed-union Bone Fracture; Periprosthetic fracture

  MAUDE report 24301946 ↗
• InjuryNov 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Bone Fracture(s)

  MAUDE report 20785659 ↗
• InjuryOct 23, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO A BONE FRACTURE. THE PATIENT FELL AND SUSTAINED A DIAPHYSEAL FEMUR FRACTURE OF HER RIGHT HIP WHICH WAS INITIALLY TREATED WITH THE PLACEMENT OF AN 18-HOLE PROXIMAL NCB PLATE. APPROXIMATELY A MONTH LATER, THE PATIENT EXPERIENCED ACUTE PAIN WHEN TURNING OVER AND FELT IT CRACK RESULTING IN HER NOT BEING ABLE TO SIT AFTER. ON X-RAY IT WAS SEEN THAT THE PLATE HAS COME OFF JUST ABOVE THE FRACTURE. THERE IS ALSO A SUSPICION OF INFECTION AS THE WOUND WAS RED AND WARM. THE PATIENT WAS REVISED APPROXIMATELY 1 WEEK LATER. DUE DILIGENCE HAS BEEN COMPLETED FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

  Patient problems: Failure of Implant; Pain; Skin Inflammation/ Irritation; Unspecified Infection

  MAUDE report 20517272 ↗
• InjuryOct 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL EVENT INFORMATION AT THIS TIME.

  Patient problems: Pain

  MAUDE report 17874638 ↗
• InjuryOct 14, 2020Fracture; Fracture

  INVESTIGATION RESULTS ARE NOW AVAILABLE.

  Patient problems: No Code Available

  MAUDE report 10676542 ↗
• InjuryOct 12, 2020Fracture; Fracture

  INVESTIGATION RESULTS ARE NOW AVAILABLE.

  Patient problems: No Code Available

  MAUDE report 10661505 ↗
• InjuryApr 7, 2020Fracture; Fracture

  INVESTIGATION RESULTS ARE NOW AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 9933239 ↗
• InjuryApr 6, 2020Material Twisted/Bent; Material Twisted/Bent

  INVESTIGATION RESULTS ARE NOW AVAILABLE.

  Patient problems: No Information

  MAUDE report 9928360 ↗
• InjuryDec 18, 2018Fracture; Fracture

  PLEASE REFER TO REPORT 0009613350 - 2018 - 01245.

  Patient problems: No Information

  MAUDE report 8173582 ↗

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