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VA-LCP 02.111.650Recalls & reported problems

Synthes GmbH · 2.4MM VA-LCP 2-CLMN VLR DSTL RADIUS PL 6H HD/5H SHAFT/RIGHT · Class 2 · Implant

All models of VA-LCP (256)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
5
Deaths reported
0
Injuries reported
3
Recalls naming it
0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982032072), received between Sep 4, 2018 and Apr 7, 2026 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (3 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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 1 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Break3
  • Material Deformation1
  • Material Twisted/Bent1

Patient problems

  • No Clinical Signs, Symptoms or Conditions2
  • No Code Available2
  • Failure of Implant1
  • Nonunion/Delayed-union Bone Fracture1

Recent adverse event reports

The 5 most recent of 5 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 24808811 ↗
  • MalfunctionJul 12, 2023Break; Break

    IT WAS REPORTED THAT A PATIENT UNDERWENT SURGERY TO IMPLANT A DISTAL RADIUS PLATE ON (B)(6)2023. IT WAS REPORTED THAT THE PLATE BROKE IN HALF POSTOPERATIVELY WHEN THE PATIENT WAS BRUSHING THEIR TEETH. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 2.4MM VA-LCP 2-CLMN VLR DSTL RADIUS PL 6H HD/5H SHAFT/RIGHT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17308480 ↗
  • InjuryOct 30, 2019Material Twisted/Bent; Material Twisted/Bent

    IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A HARDWARE REMOVAL SURGERY DUE THE VARIABLE ANGLE LCP PLATE THAT WAS BENT. ORIGINALLY, THE PATIENT WAS ORIGINALLY IMPLANTED WITH A VARIABLE ANGLE LOCKING COMPRESSION PLATE (LCP) DISTAL RADIUS SYSTEM ON AN UNKNOWN DATE. HOWEVER, ON UNKNOWN DATE, THE PATIENT FELL WHEREIN THE PATIENT'S WRIST WAS BENT DORSALLY AT ABOUT 45 DEGREES ACCOMPANIED WITH PAIN. THE IMPLANTS WERE SUCCESSFULLY EXPLANTED AND WAS REVISED WITH THE SAME PLATE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS ( PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES ONE (1) 2.4 MM VA-LCP 2-CLMN VLR DSTL RADIUS PL 6H HD / 5H SHAFT / RIGHT. THIS IS 1 OF 1 FOR REPORT (B)(4).

    Patient problems: No Code Available

    MAUDE report 9256917 ↗
  • InjuryMar 21, 2019Break; Break

    IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE DISTAL RADIUS BECAUSE THE 2.4 MM VARIABLE ANGLE LOCKING COMPRESSION PLATE (LCP) TWO-COLUMN VOLAR DISTAL RADIUS PLATE, RIGHT BROKE AND THE FRACTURE WAS NOT HEALED. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME IS UNKNOWN. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICE REPORTED: SCREW (PART/LOT UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR A 2.4 MM VARIABLE ANGLE LOCKING COMPRESSION PLATE (LCP) TWO-COLUMN VOLAR DISTAL RADIUS PLATE, RIGHT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: Failure of Implant; Nonunion/Delayed-union Bone Fracture

    MAUDE report 8440720 ↗
  • InjurySep 4, 2018Break; Break

    IT WAS REPORTED THAT, ON (B)(6) 2018, A BROKEN DISTAL RADIUS PLATE WAS EXPLANTED. THE ORIGINAL IMPLANT DATE IS UNKNOWN. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. THE PATIENT AND SURGICAL OUTCOME ARE UNKNOWN. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: No Code Available

    MAUDE report 7844010 ↗

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

Other PLATE, FIXATION, BONE devices

All PLATE, FIXATION, BONE devices →

Sources and updates

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