VA-LCP 02.115.540Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982035448), received between Dec 5, 2017 and Sep 10, 2024 — classified as 1 injury, 1 malfunction.

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

3 other recalls cover devices cleared under the same FDA submission (K102694); 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.

• MalfunctionSep 10, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED DURING INSPECTION ON AUGUST 19, 2024, SEVERAL PLATES WERE NOTED AS OLD AND APPEAR TARNISHED. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE 2.4MM VA-LCP DORSAL DISTAL RAD PLATE/RADIAL COLUMN/6H SHAFT FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20182870 ↗
• InjuryDec 5, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HARDWARE REMOVAL AND REVISION ON (B)(6) 2017 DUE TO BROKEN WRIST FUSION PLATE, NONUNION AND INFECTION. HARDWARE WAS ORIGINALLY IMPLANTED ON AN UNKNOWN DATE OF (B)(6) 2014. THE PATIENT IS REPORTED TO HAVE PRESENTED TO THE SURGEON WITH A BROKEN PLATE, THUS LEADING TO THE HARDWARE REMOVAL BEING SCHEDULED. THE SURGEON REMOVED ONE (1) WRIST FUSION PLATE, ONE (1) DISTAL RADIAL PLATE, SEVEN (7) 2.7 MM CORTEX SCREWS AND THREE (3) 3.5 MM CORTEX SCREWS, AND REPLACED THE HARDWARE WITH A K-WIRE FIXATION INCLUDING AN UNKNOWN QUANTITY OF K-WIRES AND AN ANTIBIOTIC CEMENT FOR INFECTION. IT WAS ALSO REPORTED THAT FRAGMENTS WERE GENERATED FROM THE BROKEN WRIST FUSION PLATE AND WERE RETAINED IN THE PATIENT. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. PATIENT¿S OUTCOME REPORTED AS OKAY. THIS REPORT IS FOR ONE (1) 2.4MM VA-LCP DORSAL DISTAL RAD PLATE/RADIAL COLUMN/6H SHAFT THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

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

  MAUDE report 7083551 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K102694. 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-0956-2013 · Jan 11, 2013 · Terminated
  Variable Angle Locking Compression Plate/VA-LCP Dorsal Distal Radius Plate, Part Number 02.115.431. Indicated for: Dorsally displaced fractures, Open joint reconstruction, and Cor