LCP 441.265Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982221452), received between Feb 23, 2021 and Feb 23, 2021 — 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 (K033995); 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.

• InjuryFeb 23, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT A HARDWARE REMOVAL OF BROKEN SYNTHES PLATES AND SCREWS. THERE WERE EIGHT (8) 2.7MM BROKEN SCREWS AND TWO (2) 3.5MM BROKEN SCREWS. HARDWARE WAS SUCCESSFULLY REMOVED. PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION PROVIDED. CONCOMITANT DEVICES REPORTED: 3.5MM TI LCP HOOK PLATE 3 HOLE (PART# 04.113.103, LOT # UNKNOWN, QUANTITY 1), 2.7MM/3.5MM TI VA-LCP EXT MEDL DHP 4H/LT/111MM-LONG (PART# 04.117.704, LOT # UNKNOW, QUANTITY 1), 2.7MM SCREW (PART# UNKNOWN, LOT # UNKNOWN, QUANTITY 8), 3.5MM SCREW (PART# UNKNOWN, LOT # UNKNOWN, QUANTITY 2). THIS REPORT IS FOR ONE (1) 3.5MM TI LCP® POSTEROLATERAL DISTAL HUMERUS PLATE 5H-LEFT. THIS IS REPORT 3 OF 10 FOR (B)(4). THIS COMPLAINT INVOLVES TOTAL 13 DEVICES. THIS (B)(4) REPORTS TOTAL 10 DEVICES WHILE REMAINING 3 DEVICES ARE REPORTED UNDER RELATED (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 11366794 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K033995. One submission often covers many models, so check the product and lot details in each record.

• Z-2278-2013 · Mar 8, 2013 · Terminated
  Synthes 3.5 MM LCP(R) Distal Humerus System The Synthes 3.5 MM LCP Distal Humerus System is intended for fixation of fractures of the distal humerus, olecranon, and ulna in adults