LCP 241.421Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982166982), received between Oct 10, 2018 and Nov 11, 2022 — classified as 4 injuries.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

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

  IT WAS REPORTED THAT ON (B)(6) 2021 THE PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION DUE TO RIGHT MEDIAL MALLEOLUS FRACTURE. IN RADIOLOGY (B)(6) 2021 STABLE FIXATION RIGHT SYNDESMOSIS AND RIGHT FIBULA. MEDIAL MALLEOLAR FRAGMENT WITH DISPLACEMENT. THIS REPORT IS FOR ONE (1) LCP ONE-THIRD TUB PL COLLAR 12 H/141. THIS IS REPORT 7 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: Bone Fracture(s); Physical Asymmetry

  MAUDE report 15779070 ↗
• InjuryAug 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A SURGEON WILL BE REMOVING SYNTHES PLATES AND SCREWS AND A FIBULINK DEVICE FROM AN UNKNOWN PATIENT ON (B)(6) 2021. THE REASON FOR THE REMOVAL IS PAINFUL HARDWARE. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES TEN(10) DEVICES. THIS REPORT IS FOR (1) LCP ONE-THIRD TUB PL COLLAR 12 H/141. THIS REPORT IS 1 OF 10 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 12331725 ↗
• InjuryNov 30, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT WAS IMPLANTED WITH A LOCKING COMPRESSION PLATE (LCP) ONE-THIRD TUBULAR PLATE, FIVE (5) 3.5MM CORTEX SCREWS, AND FIVE (5) 3.5MM LOCKING SCREWS ON UNKNOWN DATE. PATIENT DEVELOPED NON-UNION AND WAS RETURNED TO SURGERY ON (B)(6) 2018 WHERE ALL HARDWARE WAS REMOVED. BONE GRAFT WAS USED FOR MEDICAL INTERVENTION. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THIS REPORT IS FOR ONE (1) LCP ONE-THIRD TUBULAR PLATE. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 8120827 ↗
• InjuryOct 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT HARDWARE IMPLANTATION ON JULY 6, OF AN UNKNOWN YEAR. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT HARDWARE REMOVAL OF LOCKING COMPRESSION PLATE (LCP) LOW BEND MEDIAL DISTAL TIBIA PLATES, LOCKING COMPRESSION PLATE (LCP) ONE-THIRD TUBULAR PLATES WITH COLLAR, AND AN UNKNOWN NUMBER OF UNKNOWN SCREWS. THE REMOVAL OF DEVICES WERE DUE TO INFECTION AND TISSUE SLOUGHING. PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. THIS REPORT IS FOR ONE (1) LCP ONE-THIRD TUBULAR PLATE WITH COLLAR 12 HOLES/141MM. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 7952044 ↗

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