LCP 241.451Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982167217), received between Mar 28, 2018 and Mar 28, 2018 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K000684); 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 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH A 3.5 MM LOCKING COMPRESSION PLATE (LCP) ® ANTEROLATERAL DISTAL TIBIA PLATE ON (B)(6) 2015. ON (B)(6) 2018, THE PATIENT UNDERWENT A REMOVAL SURGERY OF THE 3.5 MM LCP® ANTEROLATERAL DISTAL TIBIA PLATE DUE TO PAIN. THERE WAS NO SURGICAL DELAY AND PATIENT OUTCOME REPORTED. HARDWARE WAS REMOVED INTACT. THIS REPORT IS FOR ONE (1) 3.5 MM LCP ANTEROLATERAL DISTAL TIBIA PLATE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 7378701 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K000684. One submission often covers many models, so check the product and lot details in each record.

• Z-1800-2015 · May 13, 2015 · Terminated
  3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws; . the Cannulated Screws are indicated for fixation of fractures, osteotomies, and non-unions of the clavicle,