LCP 02.123.043Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982042378), received between Mar 26, 2021 and Jan 16, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Material Twisted/Bent” (1 report).

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

• InjuryJan 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT REMOVAL PROCEDURE DUE TO PATIENT DISCOMFORT/PAIN AND NONUNION. DEVICES WERE IMPLANTED APPROXIMATELY 11 YEARS AGO. THIS REPORT CAPTURES THE POST-OP EVENT OF DISCOMFORT/ PAIN AND NON UNION; WHILE RELATED COMPLAINT (B)(4) CAPTURES THE INTRA-OP EVENT OF SCREW BREAKAGE. THIS REPORT IS FOR ONE (1) 3.5MM LCP PERIARTICULAR PROX HUMERUS PL 5 HOLE/145MM/LT. THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Discomfort; Nonunion/Delayed-union Bone Fracture; Pain

  MAUDE report 18519465 ↗
• MalfunctionMar 26, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT, THE HELICAL BLADE EXTRACTOR COLD WELDED WHILE USING FOR EXTRACTION OF HELICAL BLADE, INSERTED DRILL SLEEVES BROKE OFF AND PERIARTICULAR PROX HUMERUS PLATE LOCKING HOLE WAS STRIPPED AFTER INSERTING CORTICAL SCREW. SURGICAL DELAY AND PROCEDURE OUTCOME IS UNKNOWN. NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) 3.5 LCP PERIARTIC PROX HUM PL 5 H/145/LT. THIS IS REPORT 3 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11576152 ↗

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