LCP 226.662Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982159281), received between Sep 24, 2019 and Aug 11, 2022 — 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 (K000682, K041911, K082807); 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.

• InjuryAug 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020 PATIENT HAD REPAIR LEFT FEMUR MALUNION/NONUNION WITH AUTO GRAFT AND BONE GRAFTING LEFT FEMORAL HEAD. ON (B)(6) 2020, PATIENT UNDERWENT REMOVAL OF HARDWARE HIP (LEFT). CONVERSION, PREVIOUS HIP SURGERY TO TOTAL HIP ARTHROPLASTY (LEFT). OPERATIVE FINDINGS WITH NON UNION FAILED TFN, LEFT SUPERIOR ACETABULAR DEFECT. ON (B)(6) 2020 PATIENT HAD UNDERGONE IRRIGATION AND DEBRIDEMENT HIP (LEFT) - PROSTHETIC HIP INFECTION. CONCOMITANT : TRIGEN INTERTAN 11.5 MM X 18 CM 125 DEGREE (PART 71675202, LOT 19LMD7004, QUANTITY#1) INTERTAN LAG/COMPRESSION SCREW KIT 85 MM / 80 MM (PART 71677085, LOT 17BT8266, QUANTITY#1) TRIGEN (PART 71645030, LOT 20320696, QUANTITY#1). THIS REPORT IS FOR ONE (1) 4.5 CURVED BROAD LCP PL 16 HOLES/300. THIS IS REPORT 6 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture; Unspecified Infection

  MAUDE report 15208406 ↗
• InjurySep 24, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT HARDWARE REMOVAL SURGERY ON (B)(6) 2019, DUE TO A BROKEN 16 HOLES CURVED BROAD LOCKING COMPRESSION PLATE (LCP) PLATE AND A NON-UNION OF A PERIPROSTHETIC FEMUR FRACTURE. THE PLATE BROKE AS THE PATIENT WENT WEIGHT-BEARING WITH AN UNHEALED BONE. X-RAYS WERE TAKEN WITH AN UNKNOWN RESULT. THE ORIGINAL PLATE WAS REVISED TO A 20 HOLES CURVED BROAD LCP PLATE THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCE TO THE PATIENT. CONCOMITANT MEDICAL PRODUCTS: UNKNOWN SCREWS, (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 9). PERIPROSTHETIC VA LOCKING SCREW, (PART# 02.231.018, LOT# 3L11408, QUANTITY# 1). PERIPROSTHETIC VA LOCKING SCREW, (PART# 02.231.010, LOT# 1L45303, QUANTITY# 1). THREADED CERCLAGE POSITIONING PIN, (PART# 298.803, LOT# H109337, QUANTITY# 1). THREADED CERCLAGE POSITIONING PIN, (PART# 298.803, LOT# H080905, QUANTITY# 1). CERCLAGE CABLE, (PART# 298.801.01, LOT# P319928, QUANTITY# 2). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available; Nonunion/Delayed-union Bone Fracture

  MAUDE report 9111168 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K000682, K041911, K082807. One submission often covers many models, so check the product and lot details in each record.

• Z-0409-2014 · Jul 30, 2013 · Terminated
  Synthes 4.5 mm LCP Curved Condylar Plate Intended for buttressing multifragmentary distal femur fractures.