VA-LCP 04.117.801SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982106971), received between Dec 26, 2023 and Dec 26, 2023 — 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 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.

• InjuryDec 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: THE PATIENT UNDERWENT ORIF SURGERY FOR HUMERAL DIAPHYSEAL FRACTURE ABOUT 7 YEARS AGO AND A PLATE IMPLANTED. THE HUMERUS WAS RE-FRACTURED AT THE PROXIMAL END OF THAT PLATE, SO THE OUTER PLATE WAS SCHEDULED TO BE REPLACED. THIS PC IS RELATED TO (B)(4) WHICH REPORTS THE PLATE REMOVAL DIFFICULTY IN THE REPLACEMENT SURGERY. THIS PC REPORTS THE RE-FRACTURE 7 YEARS AFTER THE PRIMARY SURGERY. THIS REPORT IS FOR VA-LCP DHP 2.7/3.5 LAT R SHORT 1-HO L69 FOR (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 18395091 ↗

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