VA-LCP 03.231.001Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10886982077288), received between May 5, 2020 and Nov 21, 2025 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (10 reports).

2 other recalls cover devices cleared under the same FDA submission (K110354); 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 21, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON AN UNKNOWN DATE, THAT THE VA CONE GUIDE DID NOT SIT PROPERLY ON THE PLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23619567 ↗
• MalfunctionMay 21, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, THE AIMING ARM FOR 4.5 VA CURVED CONDYLAR SET WAS NOT LINING UP WITH THE PLATE. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22066335 ↗
• MalfunctionMay 13, 2025Device-Device Incompatibility; Material Integrity Problem; Device-Device Incompatibility; Material Integrity Problem

  ATTEMPTING TO SCREW BOLT FROM VA-LCP CODYLAR AIMING ARM (03.231.003) - BOLT 03.120.030 - INTO INSERTION HANDLE FOR AIMING ARM (03.231.001) - AND WAS NOT THREADING IN. LOOKED LIKE DAMAGED THREAD ON INSERTION HANDLE. FROM LOAN SET ZXNZTR0803 - EQUIPMENT NUMBER 3000073664.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22011910 ↗
• MalfunctionOct 3, 2023Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT A TRAY WAS DOWN BECAUSE THE THREADS HAD STRIPPED ON TWO PIECES. THE TWO PIECES NO LONGER THREAD TOGETHER AS THEY¿RE SUPPOSED AS THEY¿RE NO LONGER USABLE. THE PARTS ARE AVAILABLE FOR RETURN. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. THIS REPORT IS FOR ONE (1) INSRT HANDLE FOR 4.5 VA-LCP CONDYLAR PL THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17862861 ↗
• MalfunctionNov 8, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING A DISTAL FEMUR FRACTURE FIXATION CASE, THE AIMING ARM WAS NOT ACCURATELY TARGETING THE SCREWS INTO THE HOLES IN THE PLATE. THE AIMING ARM AND INSERTION HANDLE NEEDED TO BE REPLACED. THE SURGERY WAS DELAYED BY FIVE MINUTES DUE TO THIS EVENT. THERE WAS NO PATIENT CONSEQUENCE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE INSERTION HANDLE FOR 4.5MM VA-LCP CONDYLAR PLATE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15754538 ↗
• MalfunctionAug 8, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON UNKNOWN DATE, AFTER POST OP INSPECTION OF GRAPHIC CASE FADED. RIGHT AIMING ARM AND CONNECTING FOOT HAD WHITE RESIDUE AFTER WASH. CUTTER FROM MINI FRAG IS DULL AND EXCESSIVE FORCE TO CUT. PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME IS STABLE. THIS REPORT IS FOR ONE (1) INSRT HANDLE FOR 4.5 VA-LCP CONDYLAR PL THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15187974 ↗
• MalfunctionNov 11, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE AIMING ARM WOULDN¿T THREAD INTO THE INSERTION HANDLE. THE SURGEON USED EXCESSIVE FORCE TO TRY AND FORCE THE AIMING ARM TO THREAD INTO THE INSERTION HANDLE, WHICH EVENTUALLY LED TO THE TWO ITEMS BECOMING STUCK TOGETHER. THE AIMING ARM AND INSERTION HANDLE COULD NO LONGER BE USED. THE SURGEON THEN PERFORMED A LARGE OPEN INCISION, AS HE WAS NO LONGER ABLE TO DO THE PROCEDURE MINIMALLY INVASIVE BECAUSE OF THE PRODUCT FAULT. THIS REPORT INVOLVES ONE (1) INSERTION HANDLE FOR 4.5MM VA-LCP CONDYLAR PLATE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12795719 ↗
• MalfunctionDec 2, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON (B)(6) 2020, AN AIMING ARM LEFT NOT LINING UP WITH PLATE HOLES WHEN THEY HAVE A PLATE ATTACHED TO THE INSERTION HANDLE, AIMING ARM RIGHT NOT LINING UP WITH PLATE HOLES WHEN THEY HAVE A PLATE ATTACHED TO THE INSERTION HANDLE, AND INSERTION HANDLE SEEMS TO BE OUT OF SINK WITH BOTH AIMING ARMS. IT IS WAS DISCOVERED DURING AN INSPECTION. THERE WAS NO PATIENT INVOLVEMENT THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10935804 ↗
• InjuryMay 18, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE AIMING ARM WAS NOT LINING UP WITH THE TOP HOLE ON THE INSERTION HANDLE FOR CURVED CONDYLAR PLATE WHILE THE SURGEON WAS ATTEMPTING TO USE IT. THE SURGEON STATED THAT THIS HAS HAPPENED FOUR TIMES AND THE AIMING ARMS WERE NOT LINING UP AND A BIGGER INCISION WAS MADE TO ACCESS THE PROXIMAL HOLE. PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. CONCOMITANT DEVICES: 4.5MM VA LCP CONDYLAR PLATE (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1), AIMING ARM (PART: 03.231.004, LOT: UNKNOWN, QUANTITY: 1), AIMING ARM (PART: 03.231.003, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR AN INSERTION HANDLE FOR 4.5MM VA-LCP CONDYLAR PLATE. THIS IS REPORT 1 OF 3 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: No Code Available

  MAUDE report 10066521 ↗
• InjuryMay 5, 2020Device-Device Incompatibility; Device-Device Incompatibility

  CONCOMITANT DEVICES REPORTED: 4.5MM VA LCP CONDYLAR PLATE (PART#UNKNOWN, LOT# UNKNOWN, QUANTITY# 1); AIMING ARM FOR 4.5MM CONDYLAR PLATE/RIGHT (PART # 03.231.004, LOT # 3798908, QUANTITY 1), AIMING ARM 4.5MM CONDYLAR PLATE/LEFT (PART # 03.231.003, LOT # 3828486, QUANTITY 1).

  Patient problems: No Code Available

  MAUDE report 10026441 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K110354. One submission often covers many models, so check the product and lot details in each record.

• Z-1125-2014 · Feb 5, 2014 · Terminated
  Synthes 5.0mm Variable Locking Screw This device is part of the Variable Angle Locking Compression Plate family and this technology included variable angle Combi holes in the plat
• Z-0401-2014 · May 29, 2013 · Terminated
  Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER is used for buttressing multi fragmentary diatal femur fra