LCP 441.351Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982221780), received between Aug 28, 2018 and Jan 16, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K011335); 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.

• MalfunctionJan 16, 2024Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT A ORIF FOR DISTAL MEDIAL TIBIA & DISTAL ANTEROLATERAL TIBIA. ADT PLATE WAS USED ON DISTAL ANTEROLATERAL TIBIA, AND 1/3 CIRCLE PLATE WAS USED ON DISTAL MEDIAL TIBIA. DURING THE SURGERY, A DRILL-GUIDE/3.5MM WITH A SCREW (03.133.004) WAS NOT ATTACHED TO THE PLATE. THEREFORE, INSTEAD OF LOCKING SCREW, CORTEX ONE WAS INSERTED IN THE PLATE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A TI LCP® ONE-THIRD TUBULAR PLATE W/COLLAR 5 HOLES/57MM. THIS IS REPORT 5 OF 5 FOR (B)(4)..

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18518853 ↗
• InjuryAug 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS NOTED WHILE EXITING A VEHICLE ON (B)(6) 2018, THE PATIENT SUSTAINED A FRACTURE OF THE RIGHT TIBIA AND FIBULA. CULTURE SAMPLES WERE TAKEN WITH NO RESULTS PROVIDED AND ANTIBIOTICS WERE GIVEN POST-OPERATIVELY. THIS REPORT IS FOR A ONE-THIRD OF A TUBULAR PLATE.

  Patient problems: Unspecified Infection

  MAUDE report 7823455 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K011335. One submission often covers many models, so check the product and lot details in each record.

• Z-2816-2020 · Jul 21, 2020 · Terminated
  DePuy Synthes Trauma LCP One-Third Tubular Plate with Collar 8 Holes / 93mm - Product Usage: intended for fixation of fractures, osteotomies and non-unions of clavicle, scapula, ol
• Z-1557-2013 · Feb 22, 2013 · Terminated
  Synthes 11-Hole, 1/3 Tubular Plate DCL Plate with Collar, Part Number 241.000.011