LCP 223.521Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982157836), received between Mar 16, 2020 and Mar 16, 2020 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K000684, K082807); 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.

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

  IT WAS REPORTED ON AN UNKNOWN DATE, THE PATIENT UNDERWENT A REMOVAL PROCEDURE DUE TO AN INFECTED LEFT FIBULA HARDWARE OF A HEALED FRACTURE. IT WAS MENTIONED THAT THE SYNDESMOTIC SCREW WAS BROKEN. DURING THE PROCEDURE ALL THE HARDWARE WAS REMOVED. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT STATUS AND SURGICAL OUTCOME WERE UNKNOWN. THIS COMPLAINT INVOLVES AN UNKNOWN NUMBER OF DEVICES. THIS REPORT IS FOR ONE (1) 3.5MM LCP PLATE 2 HOLES 33MM. THIS REPORT IS 1 OF 3 FOR (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9835854 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K000684, K082807. 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,