NCB® 02.03264.015Recalls & reported problems
Zimmer GmbH · NCB PP DIST FEM PLATE, R,15 H, L. 317MM · Class 2
All models of NCB (78)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00889024297579), received between Dec 18, 2018 and May 19, 2026 — classified as 5 injuries.
The most frequently reported specific device problem is “Fracture” (4 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.
Reports received per month
Most reported problems
Device problems
- Fracture4
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Failure of Implant3
- No Code Available1
- Periprosthetic fracture1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryMay 19, 2026Fracture
IT WAS REPORTED THAT THE PATIENT HAD A RIGHT DISTAL FEMUR FRACTURE, ORIF PERFORMED WITH 9-HOLE NCB PLATE PLACED. SUBSEQUENTLY PLATE FRACTURE OCCURRED, WITH REMOVAL OF PLATE AND NEW 15-HOLE NCB PLATE PLACED APPROXIMATELY 8 MONTHS POST IMPLANTATION. DUE DILIGENCE IS IN PROCESS AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.
Patient problems: Periprosthetic fracture
MAUDE report 25216974 ↗InjuryApr 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant
MAUDE report 16794585 ↗InjuryNov 13, 2019Fracture; Fracture
ACCORDING TO LEGAL DOCUMENTS RECEIVED THE ITEM# 0203264015 LOT# UNKNOWN IS NOT MANUFACTURED BY ZIMMER BIOMET. COMPLAINT IS REJECTED AND IT WILL BE VOIDED.
Patient problems: Failure of Implant
MAUDE report 9314610 ↗InjuryAug 20, 2019Fracture; Fracture
IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY DUE TO IMPLANT FRACTURE.
Patient problems: Failure of Implant
MAUDE report 8909484 ↗InjuryDec 18, 2018Fracture; Fracture
PLEASE REFER TO REPORT 0009613350-2018-01258.
Patient problems: No Code Available
MAUDE report 8173219 ↗
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 · TerminatedNCB 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 · TerminatedVarious 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
Other Screw, fixation, bone devices
- NA 03.043.029Synthes GmbH · Screw, fixation, bone503 reports
- OSTEORAPTOR 72201995Smith & Nephew, Inc. · Screw, fixation, bone253 reports
- Control 360 SK12Treace Medical Concepts, Inc. · Screw, Fixation, Bone195 reports
- HEALIX PEEK ORTHOCORD 222205Medos International Sàrl · Screw, fixation, bone186 reports
- PRECICE® Bone Transport System STP3.5-400Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-225Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-350Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-300Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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