LCP 02.001.328SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982027740), received between May 7, 2024 and May 7, 2024 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K041911); 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.

• InjuryMay 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A RETROSPECTIVE POST MARKET STUDY (PMCF DATA) WAS RECEIVED, FOR THE TIMEFRAME OF NOVEMBER 2013 TO OCTOBER 2023, WHICH INCLUDES SAFETY RELATED DATA ON DISTAL FEMUR PLATES. THE PATIENT EXPERIENCED MALUNION/NONUNION WITH SURGICAL INTERVENTION (REMOVAL) AT 40 WEEKS AND NONUNION WITH SURGICAL INTERVENTION (REMOVAL) AT 56 WEEKS. THIS COMPLAINT IS RELATED TO (B)(4). THIS REPORT INVOLVES ONE (1) 4.5MM LCP® CURVED CONDYLAR PLATE 18H/386MM/RIGHT-STERILE. THIS IS REPORT 1 OF 10 FOR (B)(4).

  Patient problems: Malunion of Bone; Nonunion/Delayed-union Bone Fracture

  MAUDE report 19259763 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K041911. One submission often covers many models, so check the product and lot details in each record.

• Z-0409-2014 · Jul 30, 2013 · Terminated
  Synthes 4.5 mm LCP Curved Condylar Plate Intended for buttressing multifragmentary distal femur fractures.