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VA-LCP 02.111.640Recalls & reported problems

Synthes GmbH · 2.4MM VA-LCP 2-CLMN VLR DSTL RADIUS PL 6H HD/4H 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
3
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982032034), received between Sep 27, 2019 and Apr 7, 2026 — classified as 2 injuries, 1 malfunction.

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

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

  • Break2
  • Material Deformation1

Patient problems

  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
  • No Clinical Signs, Symptoms or Conditions1
  • No Code Available1
  • Nonunion/Delayed-union Bone Fracture1

Recent adverse event reports

The 3 most recent of 3 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 24808647 ↗
  • InjuryApr 25, 2022Break; Break

    IT WAS REPORTED THAT A VA-LCP PLATE BROKE FOLLOWING A DISTAL RADIUS SURGERY. THE DEVICE WAS EXPLANTED AND REPLACED WITH ANOTHER PLATE. THIS REPORT IS FOR THE VA-LCP PLATE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

    MAUDE report 14196754 ↗
  • InjurySep 27, 2019Break; Break

    IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A REVISION PROCEDURE TO REMOVE THE BROKEN VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA-LCP) DISTAL RADIUS PLATE. THE ISSUE WAS DISCOVERED WHEN PATIENT VISIT THE HOSPITAL FOR A FOLLOW UP CHECKUP. INITIALLY THE REPORTED PLATE WAS IMPLANTED AROUND 12 MONTHS AGO. IT WAS MENTIONED THAT THE DISTAL RADIAL APPEARED TO HAVE GONE TO A NONUNION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY. PATIENT STATUS WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS (PART #: UNKNOWN, LOT # UNKNOWN, QUANTITY 6). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) 2.4MM VA-LCP 2-CLMN VLR DSTL RADIUS PL 6H HD/4H SHAFT/RIGHT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: No Code Available; Nonunion/Delayed-union Bone Fracture

    MAUDE report 9130815 ↗

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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