LCP 441.449Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982222008), received between May 14, 2025 and May 14, 2025 — 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.

• InjuryMay 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD HARDWARE REMOVAL FROM THE LEFT TIBIA WITH SCREW REMOVAL SET DUE TO NON UNION.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 22017933 ↗

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,