LCP 02.123.027Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982042170), received between Dec 30, 2021 and Dec 30, 2021 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K082625); 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.

• InjuryDec 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, THE PATIENT HAD AN INFECTED NON-UNION HUMERUS WITH BROKEN UNKNOWN SCREWS. CONCOMITANT DEVICE REPORTED: LCP PROXIMAL PERIARTICULAR PROXIMAL HUMERUS PLATE(PART# 02.123.027; LOT# UNKNOWN; QUANTITY: UNKNOWN). UNK - SCREWS (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS REPORT IS FOR ONE (1) 3.5 LCP PERIARTIC PROX HUM PL 8 H/199/LT. THIS IS REPORT 10 OF 11 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture; Unspecified Infection

  MAUDE report 13119654 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K082625. One submission often covers many models, so check the product and lot details in each record.

• Z-0309-2011 · Sep 16, 2010 · Terminated
  3.5mm LCP Periarticular Proximal Humerus Plates Indicated for fractures and fracture dislocations, osteotomies, and nonunions of the proximal humerus, particularly for patients wit