LCP 02.001.300Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982027535), received between Mar 25, 2020 and Jan 9, 2024 — classified as 2 injuries.

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

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 9, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2023, DUE TO A BROKEN PLATE. PATIENT WAS STABLE DURING SURGERY AND POSTOPERATIVELY. THIS REPORT IS FOR A 4.5MM LCP® CURVED CONDYLAR PLATE 10 HOLES/242MM-LEFT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18476519 ↗
• InjuryMar 25, 2020Break; Break

  IT WAS REPORTED ON AN UNKNOWN DATE, A BROKEN 4.5 LOCKING COMPRESSION PLATE (LCP) CURVED CONDYLAR PLATE WAS FOUND IN THE DRAWER INSIDE THE TRAUMA ROOM. IT WAS MENTIONED THAT THE REPORTED PLATE HAD BEEN TAKEN OFF BY THE SURGEON ON AN UNKNOWN DATE. PATIENT STATUS AND SURGICAL OUTCOME DURING THE REMOVAL PROCEDURE WERE UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) 4.5MM LCP® CURVED CONDYLAR PLATE 10 HOLES/242MM-LEFT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 9878676 ↗

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.