NCB® 02.03263.012Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889024297463), received between Oct 16, 2023 and Oct 16, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryOct 16, 2023Fracture; Fracture

  IT WAS REPORTED PATIENT UNDERWENT A REVISION 4 MONTHS POST IMPLANTATION DUE TO A PLATE WHICH FRACTURED DUE TO FALL AT HOME WHILE USING THE TOILET. CONSEQUENTLY, A DOUBLE PLATE OSTEOSYNTHESIS PROCEDURE WAS PERFORMED TO ADDRESS THE ISSUE, NECESSITATING A REVISION SURGERY FOR THE PATIENT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant; Pain

  MAUDE report 17938043 ↗

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