VA-LCP 02.111.641Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982032058), received between Sep 25, 2018 and Apr 7, 2026 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K083694); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 7, 2026Material Deformation

  IT WAS REPORTED THAT THE DISTAL RADIUS PLATES FELL AND WERE BENT INTRAOPERATIVELY WHEN A CASE CART FELL ON THE PLATE SET. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24808775 ↗
• InjuryMay 27, 2025Migration; Migration

  THIS COMPLAINT IS FROM A DATA USE AGREEMENT (DUA). THE DUA SUMMARIZES 7 PATIENTS THAT WERE IMPLANTED WITH DEPUY SYNTHES (DPS) LCP 2.0 DISTAL ULNA PLATE. IMPLANTATION WAS BETWEEN 2008 AND 2023 AT CLEVELAND CLINIC FOUNDATION (CCF). PATIENT NUMBER 1. PATIENT IS A 76-YEAR-OLD FEMALE WHO UNDERWENT DISTAL ULNA FRACTURE FIXATION. REASON FOR IMPLANTATION WAS SUBCAPITAL FRACTURE (EXTRA-ARTICULAR) . POST OP COMPLICATION INCLUDED PAINFUL HARDWARE, LEFT ULNA -- SOME RESTRICTION OF ROTATION AND SUSPICION THAT ONE OF THESE SCREWS IN THE ULNAR PLATE IS IMPINGING ON THE RADIUS; TENDERNESS OVER LENGTH OF THE PLATE. IMPLANT(S) INVOLVED: 242.531S. COMBINATION SCREWS X7 02.111.641. COMBINATION SCREWS X8.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 22090274 ↗
• InjurySep 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IN (B)(6) 2018, THE PATIENT WAS IMPLANTED WITH HARDWARE. ON AN UNKNOWN POSTOPERATIVE DATE, THE PATIENT STATED THAT SHE COULD FEEL THE PLATE. DURING THE HARDWARE REMOVAL SURGERY ON (B)(6) 2018, THE SURGEON REMOVED THE VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA-LCP) TWO-COLUMN VOLAR DISTAL RADIUS PLATES, UNKNOWN LOCKING SCREWS AND UNKNOWN CORTEX SCREWS DUE TO PAIN. THERE WERE NO ISSUES DURING THE HARDWARE REMOVAL, ALL THE IMPLANTS CAME OUT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH GOOD PATIENT OUTCOME. THIS REPORT IS FOR A 2.4MM VA-LCP 2-COLUMN VOLAR DISTAL RADIUS PLATE 6-HOLE HEAD/4-HOLE SHAFT/LEFT. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 7906442 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K083694. One submission often covers many models, so check the product and lot details in each record.

• Z-2087-2013 · Jul 30, 2013 · Terminated
  Synthes 2.4 VA-LCP 2 CLMN VLR DSTL Radius PL 7H HD/3H Shaft/Right Product Usage: Intended for fixation of complex intra-and extra-articular fractures and osteotomies of the dista
• Z-2057-2013 · May 31, 2013 · Terminated
  Synthes 2.4mm VA-LCP Two Column Volar Distal Radius Plate and Torque limiting attachment, 1.2Nm Synthes VA-LCP Distal Radius System is intended for fixation of complex intra- and