VA-LCP 02.111.620Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982031952), received between Dec 24, 2019 and Mar 19, 2021 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (2 reports).

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.

• MalfunctionMar 19, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE THREADS ON EITHER THE VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA-LCP) TWO COLUMN VOLAR DISTAL RADIUS PLATE OR THE FOUR (4) VARIABLE ANGLE (VA) LOCKING SCREWS STARDRIVE WERE STRIPPED PRIOR TO THE CASE. EACH SCREW INSERTED INTO THE TWO RADIAL STYLOID HOLES WOULD SPIN AND NOT LOCK IN. SURGEON HAD TO REMOVE THE PLATE ALL TOGETHER AND START OVER. ANOTHER SET WAS OPENED TO GET A NEW PLATE. THE SURGERY WAS DELAYED FOR THIRTY (30) MINUTES DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) 2.4MM VA-LCP 2-CLMN VLR DSTL RADIUS PL 6H HD/2H SHAFT/RIGHT. THIS IS REPORT 1 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11530649 ↗
• InjuryMar 11, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE THAT THE 1.25MM K-WIRE BROKE OFF AND GOT STUCK IN THE DISTAL HOLE OF THE 6-HOLE VOLAR PLATE. UNABLE TO REMOVE AND HAD TO MOVE TO A 7-HOLE PLATE. THE SURGERY WAS COMPLETED WITHOUT DELAY. THE PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT ONE (2) DEVICE. THIS IS 1 OF 2 FOR REPORT (B)(4).

  Patient problems: No Code Available

  MAUDE report 9820552 ↗
• MalfunctionDec 24, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2019 DURING A DISTAL RADIUS FRACTURE SURGERY FOR A BROKEN WRIST WHEN THE SURGEON USED A SCREW AND GUIDE TO SCREW IN THE MOST DISTAL SCREW INTO THE PLATE, THE SCREW WENT THROUGH THE PLATE. THE PLATE AND SCREW WERE REMOVED AND A NEW PLATE WAS USED. THERE WAS A SURGICAL DELAY OF FIVE (5) MINUTES. THE SURGERY WAS COMPLETED WITH NO ADVERSE CONSEQUENCE TO THE PATIENT. CONCOMITANT DEVICES REPORTED: UNKNOWN SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1), UNKNOWN DRILL BIT (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1), UNKNOWN GUIDE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS REPORT IS FOR ONE 2.4MM VA-LCP 2-CLMN VLR DSTL RADIUS PL 6H HD/2H SHAFT/RIGHT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9516502 ↗

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