VA-LCP 02.117.501Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982036728), received between Dec 4, 2018 and Dec 4, 2018 — classified as 1 injury.

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

• InjuryDec 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2018, DUE TO A NONUNION AND HARDWARE FAILURE. PATIENT INITIALLY HAD AN OPEN REDUCTION AND INTERNAL FIXATION SURGERY ON (B)(6) 2018, TO TREAT A LEFT DISTAL HUMERUS FRACTURE. THE IMPLANTED DEVICES WERE VARIABLE ANGLE DISTAL HUMERUS PLATE, VARIABLE ANGLE-LCP LAT DISTAL HUMERUS PLATE, EIGHT (8) VARIABLE ANGLE LOCKING SCREW SELF-TPING WITH T8 STARDRIVE, VARIABLE ANGLE LOCKING SCREW SELF-TPING WITH T8 STARDRIVE, VARIABLE ANGLE-LCP PROXIMAL OLECRANON, AND FOUR (4) ORTEX SCREW SELF- TAPPING. THE PROCEDURE WAS COMPLETED, AND ALL HARDWARE WAS REMOVED INTACT. THE FRACTURE WAS REDUCED, AND AN UNKNOWN VARIABLE ANGLE ELBOW PLATE WITH UNKNOWN SCREWS WERE USED FOR FIXATION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THE PATIENT WAS STABLE. THIS REPORT IS FOR ONE (1) 2.7MM/3.5MM VA-LCP MEDL DSTL HUMERUS PL 1H/LT/69MM-SHORT. THIS IS REPORT 10 OF 10 FOR (B)(4). DUE TO A LIMIT OF IMPACTED PRODUCTS PER COMPLAINT, THIS COMPLAINT IS A CONTINUATION FROM COMPLAINT (B)(4).

  Patient problems: Bone Fracture(s); Impaired Healing

  MAUDE report 8128697 ↗

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