VA-LCP 02.111.531Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982031778), received between Aug 17, 2021 and Sep 20, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Slipped” (1 report).

1 other recall cover devices cleared under the same FDA submission (K092556); 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.

• InjurySep 20, 2021Mechanical Problem; No Apparent Adverse Event; Mechanical Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT REMOVAL OF DISTAL RADIUS PLATE AND GUIDE BOCK DUE TO MALFUNCTIONED. THE DISTAL RADIUS PLATE AND GUIDE BOCK WERE REMOVED AND WAS REPLACED. THE PRIMARY IMPLANTATION WAS ON (B)(6) 2021. THE DISTAL RADIUS PLATE AND GUIDE BLOCK WERE REMOVED WITH DEFECTS/MALFUNCTION AND WERE REPLACED. CONCOMITANT DEVICES REPORTED: UNKNOWN SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) 2.4MM VA-LCP 2-COL DSTL RAD PL NRW 6H HD/3H SHAFT/LT. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12495766 ↗
• InjuryAug 17, 2021Device Slipped; Device Slipped

  IT WAS REPORTED THAT ON (B)(6) 2021, PATIENT UNDERWENT A REVISION OF ORIF DISTAL RADIUS. IT WAS NOTED THAT UPON FOLLOW UP THE PATIENT HARDWARE APPEARED TO HAVE LOOSENED PER THE SURGEON AND SUBSEQUENT LOSS OF REDUCTION. INITIALLY, PATIENT HAD A ORIF DISTAL RADIUS ON (B)(6) 2021. IT IS UNKNOWN IF THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS UNKNOWN. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR (1) 2.4 VA 2-COL DRP NRW 6H HD/3H SFT/LT. THIS REPORT IS 1 OF 3 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 12331076 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K092556. One submission often covers many models, so check the product and lot details in each record.

• 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