LCP 02.123.021Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982042057), received between Apr 8, 2021 and Apr 8, 2021 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K082625); 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.

• InjuryApr 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021 PATIENT UNDERWENT REVISION SURGERY WITH BONE GRAFTING AND A NEW PROXIMAL HUMERUS PLATE AND THE ASSOCIATED SCREWS FOR NON UNION OF PROXIMAL HUMERUS, THE PRIMARY SURGERY DONE IN (B)(6) 2021. PREVIOUS HARDWARE WAS INTACT, LOCKING COMPRESSION PLATE (LCP) AND NINE (9) UNKNOWN LOCKING SCREWS WERE REMOVED SUCCESSFULLY. THERE WAS PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR ONE (1) 3.5MM LCP PERIARTICULAR PROX HUMERUS PL 2 HOLE/91MM/LT. THIS IS REPORT 1 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 11637726 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K082625. One submission often covers many models, so check the product and lot details in each record.

• Z-0309-2011 · Sep 16, 2010 · Terminated
  3.5mm LCP Periarticular Proximal Humerus Plates Indicated for fractures and fracture dislocations, osteotomies, and nonunions of the proximal humerus, particularly for patients wit