LCP 245.051Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982169570), received between Jun 8, 2017 and Jun 8, 2017 — 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.

• InjuryJun 8, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO INITIALLY UNDERWENT SURGERY FOR A LEFT, TIBIAL PLATEAU FRACTURE ON AN UNKNOWN DATE, WAS BROUGHT BACK TO THE OPERATING ROOM ON (B)(6) 2017 FOR THE REMOVAL OF TWO (2) PLATES, TWELVE (12) SCREWS AND TWO (2) K-WIRES DUE TO AN INFECTION. IT IS UNKNOWN WHEN THE INFECTION WAS IDENTIFIED OR IF THE PATIENT HAD ANY COMPLAINTS OF PAIN OR DISCOMFORT. DURING THE PROCEDURE, THE PATIENT UNDERWENT IRRIGATION AND DEBRIDEMENT (I AND D) AND THE PLACEMENT OF A DRAIN. IT WAS REPORTED THAT ALL HARDWARE WAS EASILY REMOVED AND INTACT. IT IS UNKNOWN IF THE FRACTURE WAS HEALED OR IF THERE ARE PLANS FOR ADDITIONAL SURGERY/TREATMENT. THE SURGERY WAS COMPLETED SUCCESSFULLY, WITHOUT DELAY, AND THE PATIENT REPORTED AS STABLE. THIS REPORT IS FOR ONE (1) 3.5 MM LCP RECONSTRUCTION PLATE. THIS IS REPORT 2 OF 15 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 6623768 ↗

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,