LCP 445.101Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982223425), received between May 27, 2021 and May 27, 2021 — 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 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, THE PATIENT UNDERWENT REMOVAL SURGERY DURING WHICH THE TITANIUM SMALL FRAG PLATE AND RETROGRADE NAIL WAS REMOVED, DUE TO REVISION OF NONUNION FEMUR. DEVICES WERE REPLACED WITH LARGER DIAMETER NAIL AND NEW LCP PLATE. THIS REPORT IS FOR (1) 3.5MM TI LCP RECONSTRUCTION PLATE 10 HOLES/140MM. THIS REPORT IS 6 OF 6 (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 11895881 ↗

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,