NCB®-PH 02.01362.116Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024290280), received between Mar 5, 2019 and Apr 10, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Fracture” (2 reports).

4 other recalls cover devices cleared under the same FDA submission (K061211); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 10, 2019Fracture; Fracture

  NO EVENT UPDATE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8499525 ↗
• InjuryMar 5, 2019Fracture; Fracture

  PLEASE REFER TO REPORT 0009613350-2019-00100.

  Patient problems: Foreign Body In Patient

  MAUDE report 8389588 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K061211. One submission often covers many models, so check the product and lot details in each record.

• Z-0303-2020 · Oct 10, 2019 · Terminated
  NCB Proximal Lateral Tibia, "NCB-PT LAX PROX 3H TIBIA", Various Sizes, Item Nos. 0202261205 0202261207 0202261209 0202261213 0202261305 0202261307 0202261309 0202261313
• Z-0245-2013 · Sep 4, 2012 · Terminated
  NCB-PT lateral proximal 3 hole tibial plate
• Z-0243-2013 · Sep 4, 2012 · Terminated
  NCB cancellous screw
• Z-0244-2013 · Sep 4, 2012 · Terminated
  NCB screw 4.0 self-tapping