LCP 241.265Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982166258), received between Apr 3, 2018 and Jan 18, 2019 — classified as 2 injuries.

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. How this data works · Data updated Oct 13, 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 18, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT REQUIRED A REVISION AND REMOVAL OF A BROKEN LOCKING COMPRESSION PLATE (LCP) POSTEROLATERAL DISTAL HUMERUS PLATE AND SCREWS DUE TO NONUNION. DURING THE SURGERY, THIRTEEN (13) SCREWS AND A LCP MEDIAL DISTAL HUMERUS PLATE WERE REMOVED. FRAGMENTS FROM THE BROKEN DEVICES WERE RETRIEVED. THE REVISION PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS SURGICAL DELAYED WITH AN UNKNOWN NUMBER OF MINUTES. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICE: LCP MEDIAL DISTAL HUMERUS PLATE (PART: 241.285, LOT UNKNOWN, QUANTITY 1), SCREWS (PART UNKNOWN, LOT UNKNOWN, QUANTITY 13). THIS REPORT IS FOR ONE (1) LCP POSTEROLATERAL DISTAL HUMERUS PLATE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8262612 ↗
• InjuryApr 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT UNDERWENT A PROCEDURE TO REPAIR A FRACTURE APPROXIMATELY FOURTEEN (14) YEARS PRIOR TO REMOVAL. PATIENT WAS IMPLANTED WITH ONE (1) 3.5MM LOCKING COMPRESSION PLATE (LCP) RECONSTRUCTION PLATE, ONE (1) 3.5MM LCP POSTEROLATERAL DISTAL HUMERUS PLATE, ONE (1) UNKNOWN SCREW, SEVEN (7) UNKNOWN CORTEX SCREWS, AND ONE (1) UNKNOWN LOCKING SCREW. APPROXIMATELY ONE AND ONE-HALF YEARS AGO, PATIENT BEGAN COMPLAINING OF SWELLING AND INFLAMMATION. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2018 WHERE ALL HARDWARE WAS REMOVED. DURING HARDWARE REMOVAL, SURGEON ENCOUNTERED DIFFICULTY REMOVING SOME HARDWARE. A COMPETITOR¿S SURGICAL DRILL WAS USED TO CUT THE PLATE AND BURR OFF THE SCREW HEADS, SURGICAL LUBE AND WET LAPS WERE USED TO MINIMIZE METAL SHAVINGS LEFT IN THE PATIENT. THE SURGERY WAS PROLONGED APPROXIMATELY SIXTY (60) MINUTES. PLATES WERE SUCCESSFULLY REMOVED. FIXATION WAS SUCCESSFUL AND THERE WAS NO HARM PATIENT. THIS REPORT ADDRESSES THE REVISION PROCEDURE DUE TO SWELLING AND INFLAMMATION. INTRAOPERATIVE EVENTS ARE ADDRESSED IN (B)(4). THIS REPORT IS FOR ONE (1) 3.5MM LCP POSTEROLATERAL DISTAL HUMERUS PLATE. (B)(4).

  Patient problems: Inflammation; Swelling

  MAUDE report 7392024 ↗

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