VA-LCP 04.111.730Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982102126), received between Jul 17, 2018 and Jul 17, 2018 — classified as 1 injury.

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

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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJul 17, 2018Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SURGEON REPORTED OCCASIONAL BREAKAGES OF THE 2-COLUMN VOLAR DISTAL RADIUS PLATE. THE SURGEON HAD ONE CASE IN (B)(6) 2017. SUBSEQUENT TO IMPLANTATION, THE PLATE BROKE AND THE PATIENT HAD REVISION SURGERY, THEN WENT ON TO HEAL. THERE WAS NO REPORTED DELAY IN SURGERY. THE SURGEON BELIEVES THE PLATE BREAKS THROUGH THE K-WIRE HOLES ON THE TWO ARMS OF THE PLATE. THE SURGEON FEELS THESE HOLES ARE NOT NECESSARY AND PROVIDE A WEAK POINT IN THE PLATE. THE SURGEON ALSO FEELS THAT IF THERE IS A DELAYED UNION FOLLOWING CORRECTIVE OSTEOTOMY THEN THE PLATE MAY BREAK. THIS REPORT IS FOR A 2.4MM TITANIUM (TI) VA-LCP 2-CLMN VLR DST RADIUS PL 7H HD/3H SHAFT/RT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7694944 ↗

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