NCB® 02.02264.015Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00889024292857), received between Nov 13, 2019 and Jun 9, 2025 — classified as 7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJun 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL SURGERY DUE TO PERIPROSTHETIC FRACTURE. DURING THIS PROCEDURE, A 15 HOLE RIGHT DISTAL FEMUR NCB PLATE WAS USED, ALONG WITH CABLES AND SCREWS/LOCKING CAPS TO STABILIZE THE PATIENT ORIGINAL FRACTURE. HOWEVER. THIS FRACTURE FAILED TO HEAL CORRECTLY AND RESULTED IN A DISPLACED NONUNION FRACTURE. SUBSEQUENTLY, APPROXIMATELY 5 MONTHS POST IMPLANTATION, UNDERWENT A REVISION SURGERY. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 22168315 ↗
• InjuryJun 6, 2024Fracture; Fracture

  IT WAS REPORTED PATIENT UNDERWENT RIGHT HIP REVISION APPROXIMATELY 5 MONTHS POST-IMPLANTATION DUE TO NCB®, PERIPROSTHETIC FEMUR PLATE BROKEN. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 19480224 ↗
• InjuryJun 14, 2021Fracture; Fracture

  PATIENT RECEIVED AN IMPLANT ON AN OSTEOSYNTHESIS PLATE PLACED 6 YEARS AGO ON AN UNKNOWN SIDE. IT WAS REPORTED THAT THE PATIENT HAD FRACTURED THE FEMUR ON AN UNKNOWN DATE IN (B)(6) 2020. REVISION SURGERY IS YET TO OCCUR TO REPLACE THE FRACTURED IMPLANT.

  Patient problems: Failure of Implant

  MAUDE report 11991801 ↗
• InjuryAug 11, 2020Fracture; Fracture

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

  Patient problems: No Code Available

  MAUDE report 10390722 ↗
• InjuryMay 20, 2020Fracture; Fracture

  INVESTIGATION RESULTS ARE NOW AVAILABLE.

  Patient problems: Fall

  MAUDE report 10073631 ↗
• InjuryApr 7, 2020Fracture; Fracture

  IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON UNKNOWN DATE DUE TO IMPLANT FRACTURE.

  Patient problems: Failure of Implant

  MAUDE report 9933260 ↗
• InjuryNov 13, 2019Fracture; Fracture

  ACCORDING TO LEGAL DOCUMENTS RECEIVED THE ITEM# 0202264015 LOT# UNKNOWN IS NOT MANUFACTURED BY ZIMMER BIOMET. COMPLAINT IS REJECTED AND IT WILL BE VOIDED.

  Patient problems: Failure of Implant

  MAUDE report 9314595 ↗

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