LCP 441.371Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982221827), received between Sep 12, 2025 and Sep 12, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K011335); 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.

• InjurySep 12, 2025Break; Break

  DURING A REGULAR CALL WITH THE SURGEON, THE SURGEON REPORTED BREAKAGE OF THE ONE THIRD TUBULAR PLATE AND NON-UNION. THE EVENT REQUIRED A SECONDARY SURGERY.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 23042757 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K011335. One submission often covers many models, so check the product and lot details in each record.

• Z-2816-2020 · Jul 21, 2020 · Terminated
  DePuy Synthes Trauma LCP One-Third Tubular Plate with Collar 8 Holes / 93mm - Product Usage: intended for fixation of fractures, osteotomies and non-unions of clavicle, scapula, ol
• Z-1557-2013 · Feb 22, 2013 · Terminated
  Synthes 11-Hole, 1/3 Tubular Plate DCL Plate with Collar, Part Number 241.000.011