VA-LCP 02.117.402Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982036520), received between Feb 15, 2023 and Mar 6, 2026 — classified as 2 injuries.

1 other recall cover devices cleared under the same FDA submission (K120070); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON(B)(6) 2026, THAT THE PATIENT WAS REVISED AND HARDWARE WAS REMOVED DUE TO NON UNION AND MAL-UNION.

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

  MAUDE report 24530360 ↗
• InjuryFeb 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT PRESENTED WITH A NON-UNION DISTAL HUMERUS FRACTURE PREVIOUSLY TREATED IN 2022, UTILIZING SYNTHES VARIABLE ANGLE PLATES DISTAL HUMERUS PLATES. X-RAY CONFIRMED A NON-UNION OF THE MEDIAL CONDYLE/COLUMN. ALL HARDWARE WAS INTACT, NOTHING WAS BROKEN. THE SURGEON REMOVED THE PREVIOUS IMPLANTED MEDIAL PLATE, INSERTED BONE GRAFT, AND FIXATED WITH A NEW MEDIAL PLATE. THERE WERE PATIENT CONSEQUENCES. THIS REPORT IS FOR A 2.7MM/3.5MM VA-LCP MEDL DSTL HUMERUS PL 2H/RT/82MM-MEDIUM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 16378759 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K120070. One submission often covers many models, so check the product and lot details in each record.

• Z-0124-2016 · Sep 28, 2015 · Terminated
  Synthes 2.7MM/3.5MM VA-LCP Medial Distal Humerus Plates 10H/RT/186mm- Sterile and Synthes 2.7MM/3.5MM VA-LCP Extended Medial Distal Humerus Plates 10H/RT/189mm-Sterile The Synthes