LCP 236.511Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982160836), received between Jun 9, 2020 and Jun 9, 2020 — 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 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT RETURNED TO SURGERY FOR REVISION OLECRANON PLATE. THE REVISION WAS DUE TO FRACTURE NEVER PROPERLY BEING REDUCED IN THE PREVIOUS SURGERY. ALL HARDWARE WAS INTACT. THERE WAS NO SURGICAL DELAY REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT CONSEQUENCE REVISED ORIF OF OLECRANON FRACTURE. THIS (B)(4) CAPTURES 9 UNKNOWN SCREWS AND 1 PLATE, WHILE (B)(4) CAPTURES THREE (3) OUT OF TWELVE (12) UNKNOWN SCREWS. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR ONE (1) 3.5MM LCP OLECRANON PLATE 10 HOLES/LEFT/190MM. THIS REPORT IS 1 OF 10 FOR (B)(4).

  Patient problems: No Code Available; Nonunion/Delayed-union Bone Fracture

  MAUDE report 10134366 ↗

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,