LCP 02.123.022Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982042071), received between Oct 25, 2018 and Jan 14, 2019 — classified as 2 injuries.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, PATIENT UNDERWENT A HARDWARE REMOVAL OF PROXIMAL HUMERUS PLATE DUE TO NONUNION. PATIENT WAS REVISED TO SYNTHES EX HUMERUS NAIL. ORIGINAL PROXIMAL HUMERUS PLATE IMPLANTED ON (B)(6) 2018. IT IS UNKNOWN IF THERE IS SURGICAL DELAY. THE PROCEDURE AND PATIENT OUTCOME IS UNKNOWN. TIS REPORT IS FOR ONE (1) 3.5MM LCP PERIARTICULAR PROX HUMERUS PL 4 HOLE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 8245753 ↗
• InjuryOct 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT HARDWARE REMOVAL OF ONE (1) PERIARTICULAR PROXIMAL HUMERUS PLATE, THREE (3) UNKNOWN CORTEX SCREWS AND EIGHT (8) UNKNOWN LOCKING SCREWS DUE TO PAIN. THE HARDWARE WAS ORIGINALLY IMPLANTED ON (B)(6) 2017. ALL HARDWARE WAS SUCCESSFULLY REMOVED WITH NO ISSUES. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A 3.5MM LOCKING COMPRESSION PLATE (LCP). THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 8004758 ↗

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