LCP 241.454Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982167279), received between Aug 18, 2017 and Aug 18, 2017 — classified as 1 injury.

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

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 18, 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.

• InjuryAug 18, 2017Break; Break

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON (B)(6) 2017 DUE TO A NON-UNION AND PAIN. X-RAY TAKEN AT A PRIOR DATE SHOWED ONE (1) PREVIOUSLY IMPLANTED PLATE WAS BROKEN AND A REVISION SURGERY WAS SCHEDULED TO REPLACE THE PLATE. RADIOLOGY IMAGING WAS TAKEN ON (B)(6) 2017 FOR DOCUMENTATION AND CONFIRMED THE BROKEN PLATE. THE INITIAL SURGERY WAS IN (B)(6) 2016. ONE (1) NEW PLATE AND SCREW(S) WERE IMPLANTED. THE REVISION SURGERY WAS SUCCESSFUL AND THE PATIENT IS STABLE. THERE WAS NO SURGICAL DELAY. CONCOMITANT DEVICES REPORTED: SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant; Impaired Healing; Pain

  MAUDE report 6803859 ↗

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,