LCP 241.277Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982166456), received between Mar 20, 2017 and Mar 20, 2017 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K033995); 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.

• InjuryMar 20, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS IMPLANTED WITH FOUR UNKNOWN SYNTHES 3.5 CORTEX SCREWS, EIGHT UNKNOWN 2.7 MM VAL SCREWS, SIX UNKNOWN 3.5 LOCKING SCREWS, A 7 HOLE 3.5 MM LCP POSTEROLATERAL DISTAL HUMERUS PLATE, AND A 6 HOLE EXTRA LONG 2.7/3.5 MM VA-LCP EXTENDED MEDIAL DISTAL HUMERUS PLATE TO TREAT A LEFT DISTAL HUMERUS FRACTURE ON AN UNKNOWN DATE. ON AN UNKNOWN DATE POSTOPERATIVELY, IT WAS IDENTIFIED THAT THE PATIENT HAD DEVELOPED A NON-UNION OF THE FRACTURE. ON (B)(6) 2017, THE PATIENT WAS RETURNED TO THE OPERATING ROOM AND ALL OF THE DEVICES WERE REMOVED EASILY AND INTACT. THE NON-UNION WAS DEBRIDED AND GRAFTED AND THE PATIENT WAS REVISED WITH LONGER PLATES. NO DELAY IN SURGERY WAS REPORTED AND NO ADVERSE EVENTS AGAINST THE PATIENT WERE IDENTIFIED. PROCEDURE WAS COMPLETED SUCCESSFULLY AND PATIENT OUTCOME WAS REPORTED AS OKAY. THIS REPORT IS FOR ONE (1) 3.5 MM LCP POSTEROLATERAL DSTL HUMERUS PL-LAT SUPPORT 7H-LT. THIS IS REPORT 1 OF 5 FOR (B)(4).

  Patient problems: Impaired Healing; No Code Available

  MAUDE report 6416942 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K033995. One submission often covers many models, so check the product and lot details in each record.

• Z-2278-2013 · Mar 8, 2013 · Terminated
  Synthes 3.5 MM LCP(R) Distal Humerus System The Synthes 3.5 MM LCP Distal Humerus System is intended for fixation of fractures of the distal humerus, olecranon, and ulna in adults