NCB® 02.02263.012Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00889024292697), received between Dec 19, 2019 and Feb 18, 2025 — classified as 5 injuries, 1 malfunction.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 18, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE, THE PLATE WAS FRACTURED PRIOR TO BEING IMPLANTED IN THE PATIENT, THIS PLATE WAS DISCARDED, AND ANOTHER NCB PLATE WAS USED FOR THE OPERATION. NO HARM TO THE PATIENT. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21401366 ↗
• InjuryMar 26, 2021Fracture; Fracture

  INVESTIGATION RESULTS ARE NOW AVAILABLE.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 11573785 ↗
• InjuryOct 12, 2020Fracture; Fracture

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

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 10661499 ↗
• InjuryOct 12, 2020Fracture; Fracture

  INVESTIGATION RESULTS ARE NOW AVAILABLE.

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 10661487 ↗
• InjuryApr 23, 2020Fracture; Fracture

  IT WAS REPORT THAT PATIENT UNDERWENT REVISION SURGERY DUE TO IMPLANT FRACTURE 3 WEEKS AFTER IMPLANTATION DUE TO IMPLANT FRACTURE AS A CONSEQUENCE OF A SLIP WHILE SITTING.

  Patient problems: Failure of Implant

  MAUDE report 9989618 ↗
• InjuryDec 19, 2019Fracture; Fracture

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

  Patient problems: No Information

  MAUDE report 9493815 ↗

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-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
• 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