NCB® 02.00024.301Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889024081697), received between Sep 8, 2026 and Sep 8, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Packaging Problem” (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 18, 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.

• MalfunctionSep 8, 2026Packaging Problem

  It was reported that the products arrived at the distributorship and were found to be non-conforming with a hair-like substance in the packaging. No patient or customer was involved in the event. Attempts have been made and no further information has been provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50670388 ↗

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 02