LCP 442.491Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982222886), received between Jun 19, 2018 and Jun 19, 2018 — classified as 1 injury.

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.

• InjuryJun 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT COULD FEEL ONE (1) PREVIOUSLY IMPLANTED LOCKING COMPRESSION PLATE (LCP) DISTAL RADIUS VOLAR PLATE UNDER THEIR SKIN AND IT BOTHERED THEM. THE PATIENT CLARIFIED THAT THEY DID NOT FEEL ANY PAIN. SUBSEQUENTLY, ON (B)(6) 2018, THE PATIENT UNDERWENT REMOVAL OF THE ENTIRE CONSTRUCT CONSISTING OF ONE (1) LCP DISTAL RADIUS VOLAR PLATE AND SIX (6) UNKNOWN LOCKING SCREWS. ALL DEVICES WERE REMOVED INTACT AND THE PATIENT WAS NOT REVISED TO ANY OTHER IMPLANTS. THE HARDWARE REMOVAL WAS REPORTED TO HAVE BEEN COMPLETED SUCCESSFULLY. THIS COMPLAINT IS FOR ONE (1) LCP DISTAL RADIUS VOLAR PLATE (PART NUMBER 442.491, LOT NUMBER UNKNOWN, QUANTITY 1). CONCOMITANT DEVICES REPORTED: LOCKING SCREWS (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 6). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Discomfort

  MAUDE report 7615117 ↗

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