LCP 02.111.900Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982032454), received between Oct 11, 2018 and Sep 16, 2020 — classified as 2 injuries.

1 other recall cover devices cleared under the same FDA submission (K113364); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2020 THAT A PATIENT UNDERWENT ULNAR REDUCTION SURGERY OF THE RIGHT WRIST ON (B)(6) 2016. THE PATIENT HAS EXPERIENCED HYPERSENSITIVITY SOMETIMES WHERE HER ARM IS NEAR AN ELECTRICITY SOURCE. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) 2.7MM LCP ULNA OSTEOTOMY PLATE 6 HOLES. THIS IS REPORT 1 OF 7 FOR (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction; No Code Available

  MAUDE report 10540921 ↗
• InjuryOct 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REMOVAL OF ONE (1) LOCKING COMPRESSION PLATE (LCP) ULNA OSTEOTOMY PLATE 6 HOLES AND SIX (6) UNKNOWN 2.7MM DIAMETER SCREWS ON (B)(6) 2018 DUE TO NONUNION. THE PATIENT UNDERWENT AN ULNA SHORTENING OSTEOTOMY AND WAS IMPLANTED WITH THE ORIGINAL HARDWARE ON (B)(6) 2016. PATIENT WAS REVISED WITH A SYNTHES 3.5MM LOCKING COMPRESSION PLATE (LCP) WITH BONE GRAFT. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. SURGICAL PROCEDURE WAS SUCCESSFUL AND PATIENT OUTCOME WAS STABLE. THIS REPORT IS FOR ONE (1) 2.7MM LCP ULNA OSTEOTOMY PLATE 6 HOLES. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 7956975 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K113364. One submission often covers many models, so check the product and lot details in each record.

• Z-1274-2014 · Jan 7, 2014 · Terminated
  Drill Template and the Saw Guide for the Ulna Osteotomy System. Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bon