LCP 241.151Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982165985), received between Jun 29, 2018 and May 10, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Migration” (1 report).

1 other recall cover devices cleared under the same FDA submission (K000684); 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.

• InjuryMay 10, 2024Migration; Migration

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE PATIENT WAS IMPLANTED WITH LCP T-PLATES 3.5 IN THE TIBIA WITH DPS SCREWS AND WITH ADDITIONAL PLATES ADJUNCTIVE FIXATION (LATERAL TIBIAL PLATEAU PLATE (SYNTHES). AT 12 WEEKS POST-OP IMPLANT PROMINENCE WAS EXPERIENCED. AT 24 WEEKS POST-OP SURGICAL TREATMENT FOR HARDWARE REMOVAL PERFORMED FOR REMOVAL OF 2 PROXIMAL LOCKING SCREWS. THE PATIENT HAS RECOVERED. THIS REPORT INVOLVES ONE (1) 3.5MM LCP T-PLATE 3H HEAD/ 5H SHAFT/67MM-RIGHT ANGLE. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19285237 ↗
• InjuryJun 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION DUE TO NON¿UNION AND INFECTION. ONE (1) VARIABLE ANGLE DISTAL PLATE, ELEVEN (11) VARIABLE ANGLE LOCKING SCREWS, TWO (2) 3.5 CORTEX SCREWS, ONE (1) LOCKING COMPRESSION PLATE PROXIMAL MEDIA TIBIA, ONE (1) T PLATE, SIX (6) LOCKING COMPRESSION PLATE SCREWS, AND FIVE (5) CORTEX SCREWS WERE REMOVED AND WERE REPLACED WITH A NEW VA DISTAL FEMUR PLATE AND A RETROGRADE/ANTEGRADE FEMORAL NAIL (RFNA). THE DATE OF THE ORIGINAL PROCEDURE IS UNKNOWN BUT WAS REPORTED MORE THAN SIX MONTHS BEFORE THE REPORTED ISSUES. IT WAS NOTED THE NON-UNION OCCURRED IN THE DISTAL FEMUR AND THE INFECTION DEVELOPED IN THE PROXIMAL TIBIA. ON AN UNKNOWN DATE, THE TIBIA WAS WASHED OUT AND DEBRIDED AND PLATES REMOVED. THE FEMUR WAS TO BE BONE GRAFTED; HOWEVER, IT WAS DISCOVERED A LARGE FRAGMENT OF BONE HAD DIED. THIS WAS REMOVED AND CEMENT SPACER WAS INSERTED. FEMORAL IMPLANTS REMAINED IN SITU. ON (B)(6) 2018, THE FEMORAL FIXATION WAS REVISED WITH VA DISTAL FEMUR PLATE AND RAFN NAIL AND BONE GRAFT. TIBIA IMPLANTS REMOVED, WASHED OUT AND SINUS EXCISED AS IT WAS STILL INFECTED. THERE WAS NO DELAY

  Patient problems: Unspecified Infection

  MAUDE report 7651037 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K000684. One submission often covers many models, so check the product and lot details in each record.

• Z-1800-2015 · May 13, 2015 · Terminated
  3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws; . the Cannulated Screws are indicated for fixation of fractures, osteotomies, and non-unions of the clavicle,