VA-LCP 02.117.702Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982037183), received between May 11, 2018 and Jun 11, 2019 — classified as 3 injuries.

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

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 11, 2019No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A HARDWARE REMOVAL DUE TO PAIN. ONE (1) VARIABLE ANGLE LOCKING COMPRESSION PLATE POSTEROLATERAL DISTAL HUMERUS PLATES WITH LATERAL SUPPORT, ONE (1) VARIABLE ANGLE LOCKING COMPRESSION PLATE EXTENDED MEDIAL DISTAL HUMERUS PLATES, ONE (1) CORTEX SCREW SELF-TAPPING 50MM, ONE (1) CORTEX SCREW SELF-TAPPING 20MM, ONE (1) CORTEX SCREW SELF-TAPPING 24MM, THREE (3) CORTEX SCREWS SELF-TAPPING 20MM, ONE (1) CORTEX SCREW SELF-TAPPING 22MM, ONE (1) CORTEX SCREW SELF-TAPPING 26MM, ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 14MM, ONE VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 16MM, ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 22MM, ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 30MM, ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 40MM AND ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 50MM. SOME SCREWS WERE BROKEN AND LEFT. OTHER SCREWS WERE LEFT IN THE BODY. IT IS UNKNOWN IF WHAT SCREWS WERE LEFT/BROKEN. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. P

  Patient problems: No Code Available; Pain

  MAUDE report 8686955 ↗
• InjuryJul 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT IMPLANTATION OF TWO (2) LOCKING COMPRESSION PLATE (LCP) DISTAL HUMERAL PLATES AND UNKNOWN SCREWS ON (B)(6) 2018. ON AN UNKNOWN DATE, PATIENT DEVELOPED HARDWARE ISSUES. ON (B)(6) 2018, PATIENT UNDERWENT HARDWARE REMOVAL DUE TO THE PLATES BREAKING THROUGH THE SKIN. THERE WAS NO SURGICAL DELAY REPORTED. PROCEDURE WAS COMPLETED SUCCESSFULLY AND PATIENT STATUS WAS STABLE. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: Pocket Erosion

  MAUDE report 7681376 ↗
• InjuryMay 11, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT WAS INITIALLY TREATED FOR AN INTRA-ARTICULAR DISTAL HUMERUS FRACTURE ON (B)(6) 2018 WITH 2.7/3.5MM VARIABLE ANGLE (VA) LOCKING COMPRESSION PLATE (LCP) MEDIAL AND LATERAL DISTAL HUMERUS PLATES. THE PATIENT HAD A SUBSEQUENT PLATE BREAKAGE OF THE 2.7/3.5MM VA LCP MEDIAL DISTAL HUMERUS PLATE AND WAS BROUGHT TO THE OPERATING ROOM ON (B)(6) 2018 FOR REVISION SURGERY. THE SURGERY ON (B)(6) 2018 INVOLVED REMOVAL OF THE BROKEN PLATE AND FIVE SCREWS, AND WAS REVISED TO A LONGER 2.7/3.5MM VA LCP MEDIAL DISTAL HUMERUS PLATE AND AN ADDITIONAL 2.7/3.5MM VA LCP POSTEROMEDIAL DISTAL HUMERUS PLATE. CONCOMITANT DEVICES REPORTED: SCREWS (PART # 02.111.042, LOT # UNKNOWN, QUANTITY 1), SCREWS (PART # 02.111.038, LOT # UNKNOWN, QUANTITY 1), SCREWS (PART # 02.111.040, LOT # UNKNOWN, QUANTITY 1), SCREWS (PART # 204.826, LOT # UNKNOWN, QUANTITY 1), SCREWS (PART # 204.828, LOT # UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES ONE DEVICE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 7506522 ↗

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