LCP 247.375Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982170897), received between Oct 15, 2020 and Apr 11, 2024 — classified as 2 injuries.

4 other recalls cover devices cleared under the same FDA submission (K063049); 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 16, 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 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IN COLLABORATION WITH DEPUY SYNTHES, DR. , TOGETHER WITH CLEVELAND CLINIC FOUNDATION (CCF) DATABASE DESIGNERS, PROGRAM MANAGERS, RESEARCH ASSISTANTS, AND BIOSTATISTICIANS, HAS DEVELOPED A REPORT THAT SUMMARIZES SAFETY AND EFFECTIVENESS DATA ON 67 PATIENTS WHO UNDERWENT HAND SURGERY AT CCF BETWEEN 2008 AND 2023 UTILIZING DEPUY SYNTHES (DPS) HAND PLATES. IMPLANTS INVOLVED WERE LCP COMPACT HAND PLATES OR VA LOCKING HAND SYSTEM. 3 PATIENTS WERE NOTED TO HAVE MORE THAN ONE PLATE IMPLANTED. DPS SCREWS WERE INVOLVED. PATIENT #24 39-YEAR-OLD FEMALE WAS IMPLANTED WITH A LCP COMPACT HAND PLATES / MODULAR MINI FRAGMENT LCP SYSTEM (247.375) WITH 3 SCREWS. POST OP COMPLICATION WAS REPORTED FOR PAINFUL HARDWARE RIGHT FOOT; NON-UNION. THE COMPLICATION IS NOTED TO BE RELATED TO THE PROCEDURE OR IMPLANTS. THERE IS NO DEVICE FAILURE NOTED. TREATMENT: REMOVAL OF PAINFUL HARDWARE RIGHT FOOT. THIS REPORT IS FOR A 2.4MM LCP (TM) PLATE 5 HOLES 44MM. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture; Pain

  MAUDE report 19088174 ↗
• InjuryOct 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT HARDWARE REMOVAL IN TIBIA DUE TO INFECTION OR NONUNION, AND AN UNKNOWN EXTERNAL FIXATION WAS PLACED. INITIALLY, THE PATIENT WAS IMPLANTED WITH A LOCKING COMPRESSION PLATE (LCP) ON (B)(6) 2020. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) 2.4MM LCP(TM) PLATE 5 HOLES 44MM. THIS IS REPORT 4 OF 10 FOR (B)(4).

  Patient problems: No Code Available; Nonunion/Delayed-union Bone Fracture; Unspecified Infection

  MAUDE report 10685559 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K063049. One submission often covers many models, so check the product and lot details in each record.

• Z-2389-2016 · Jun 28, 2016 · Terminated
  Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Plate, Fixation, Bone,
• Z-0323-2016 · Nov 2, 2015 · Terminated
  2.4MM locking screw SLF-TPNG with Stardrive Recess 18 mm. Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone frag
• Z-0167-2016 · Oct 6, 2015 · Terminated
  2.7 mm Locking Screw SLF-TPNG with T8 Stardrive Recess 12mm. The Synthes modular Mini Fragment LCP System is intended for fixation of fractures, osteotomies, nonunions, replantati
• Z-0380-2014 · Jul 31, 2013 · Terminated
  2.4 and 2.7 MM Locking Screw SLF-TPNG with T8 Stardrive Recess 12 MM Fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragmen