VA-LCP 02.117.802Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982037404), received between Mar 5, 2024 and Mar 13, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (2 reports).

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.

• MalfunctionMar 13, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON 26-FEBRUARY-2024, THE PLATES IN QUESTION HAD HOLES THAT WERE STRIPPED OUT AND WOULDN¿T HOLD LOCKING SCREWS. THE ISSUE WAS DISCOVERED PRE-OP, THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.7MM/3.5MM VA-LCP LAT DISTAL HUMERUS PL 2H/RT/82MM-MED. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18897126 ↗
• MalfunctionMar 5, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2024, THE SURGEON WAS PERFORMING A DUAL PLATING OF THE DISTAL HUMERUS, AND MULTIPLE VARIABLE ANGLE LOCKING SCREWS WOULD NOT LOCK INTO EACH PLATE. STANDARD OPERATING PROCEDURE WAS PERFORMED FOR EACH SCREW THAT CONSISTED OF USING A CONE GUIDE FOR DRILLING FOLLOWED BY MEASURING AND INSERTION OF THE SCREW WITH TORQUE LIMITER. THERE WERE NO PATIENT OUTCOMES REPORTED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF 15 MINUTES. THIS REPORT INVOLVES ONE 2.7MM/3.5MM VA-LCP LAT DISTAL HUMERUS PL 2H/RT/82MM-MED. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18836330 ↗

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