LCP 442.492Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982222893), received between Jan 16, 2018 and Jan 16, 2018 — classified as 1 injury.

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

3 other recalls cover devices cleared under the same FDA submission (K012114, K091644); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJan 16, 2018Bent; Bent

  IT WAS REPORTED THAT A PATIENT WAS IMPLANTED WITH A SYNTHES TITANIUM (TI) LOCKING COMPRESSION PLATE (LCP) DISTAL RADIUS PLATE VOLAR/LEFT-LONG, FOUR (4) UNKNOWN 2.4MM TI LOCKING SCREWS, AND FOUR (4) UNKNOWN 2.4MM TITANIUM CORTEX SCREWS TO TREAT AN UNKNOWN RADIUS FRACTURE ON AN UNKNOWN DATE IN 2017. ON AN UNKNOWN DATE POSTOPERATIVELY, IT WAS IDENTIFIED THAT THE PLATE HAD BENT AND THERE WAS A DORSAL DISPLACEMENT OF THE FRACTURE, IDENTIFIED ON PREOPERATIVE X-RAYS. ON (B)(6) 2017, THE PATIENT WAS RETURNED TO THE OPERATING ROOM WHERE THE IMPLANTS WERE REMOVED INTACT AND THE PATIENT WAS REVISED USING A DIFFERENT SYNTHES DEVICE. PATIENT OUTCOME WAS NOT REPORTED. CONCOMITANT DEVICES REPORTED: 2.4MM TI LOCKING SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 4), 2.4MM TI CORTEX SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 4), THIS REPORT IS FOR ONE (1) TI LCP(TM) DISTAL RADIUS PLATE TI LCP(TM) DISTAL RADIUS PLATE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 7195998 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K012114, K091644. One submission often covers many models, so check the product and lot details in each record.

• Z-2389-2016 · Jun 28, 2016 · Terminated
  Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Plate, Fixation, Bone,
• Z-0323-2016 · Nov 2, 2015 · Terminated
  2.4MM locking screw SLF-TPNG with Stardrive Recess 18 mm. Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone frag
• Z-0489-2007 · Dec 5, 2006 · Terminated
  LCP Volar Distal Radius Plate Extra Articular 4H HD-RT-Long, LCP Volar Distal Radius Plate 2.4 mm, Catalog number 242.465