LCP 442.490Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982222879), received between Jan 30, 2024 and Jan 30, 2024 — classified as 1 malfunction.

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

• MalfunctionJan 30, 2024Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT AN OPEN REDUCTION/INTERNAL FIXATION SURGERY FOR A DISTAL ULNA FRACTURE WITH THE DISTAL RADIUS PLATE AND LOCKING SCREWS ON (B)(6) 2024. AFTER THE SURGEON FIXED THE PLATE WITH THREE CORTEX SCREWS, HE INSERTED LOCKING SCREWS AT THE DISTAL AND PROXIMAL ENDS, BUT THE LOCKING SCREWS PENETRATED THE SCREW HOLES IN THE PLATE. THE SALES REPRESENTATIVE ALSO CONFIRMED THAT THE LOCKING SCREW PENETRATED THROUGH THE SCREW HOLE WITHOUT GETTING CAUGHT. THE SURGEON DETERMINED THAT FIXATION COULD NOT BE ACHIEVED IN THIS CONDITION, SO THE DISTAL RADIUS PLATE WAS REMOVED, AND THE WOUND WAS SWITCHED TO A FIXATION WITH A K-WIRE AND CLOSED. THE SURGERY WAS EXTENDED BY 30 MINUTES DUE TO THE EVENT, AND THE PATIENT STATUS/OUTCOME WAS REPORTED TO BE STABLE. THIS REPORT INVOLVES ONE 2.4MM TI LCP(TM) DISTAL RADIUS PLATE-STRAIGHT/LONG. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18608802 ↗

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