VA-LCP 02.115.350SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982035332), received between Sep 16, 2024 and Sep 16, 2024 — classified as 1 injury.

3 other recalls cover devices cleared under the same FDA submission (K102694); 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 18, 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.

• InjurySep 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT SURGERY TO FRACTURE REPAIR OF AN OPEN, DISPLACED, COMPLEX (COMMINUTED) FRACTURE OF THE DISTAL TIBIA ON THE RIGHT SIDE USING TWO 3.5MM HEADED TITANIUM SCREWS 42MM LONG WITH LONG THREAD WITH SUPPLEMENTAL FIXATION USING A DEPUY SYNTHES 2.4MM VARIABLE ANGLE LCP DORSAL DISTAL RADIUS T-PLATE WITH A 3-HOLE HEAD AND A 5-HOLE SHAFT (51MM LONG, STAINLESS STEEL). SUBJECT ALSO UNDERWENT A FRACTURE REPAIR OF THE FIBULA AND RECEIVED A DEPUY SYNTHES 2.7MM/3.5MM LCP POSTEROLATERAL DISTAL FIBULA PLATE (4 HOLES, 90MM IN LENGTH, LEFT ORIENTATION, MADE OF STAINLESS STEEL). OPERATING ROOM TIME WAS 60 MINUTES. POST-OPERATIVE TREATMENT: BRACING/IMMOBILIZATION: NON WEIGHT BEARING FOR 10 WEEKS, PARTIAL WEIGHT BEARING UNTIL 12 WEEKS POST OP IN A BOOT, FULL WEIGHT BEARING IN A GYM SHOE AT 12 WEEKS POST OP; AT 4.5 MONTHS POST-OPERATIVE PATIENT HAD HARDWARE REMOVAL AND WAS INSTRUCTED TO WEIGHTBEAR AS TOLERATED; PAIN MEDICATION: HYDROCODONE ACETAMINOPHEN (5-325MG TAKEN EVERY 4 HRS OR AS NEEDED FOR 2 MONTHS), CLINDAMYCIN (300MG 3X/DAY FOR 10 DAYS STARTING 4 WEEKS POST-OPERATIVE) TO PREVENT INFECTION. WAS TAKING GABAPENTIN (400MG ONCE DAILY FOR SEIZUR

  Patient problems: Impaired Healing; Pain; Unspecified Infection

  MAUDE report 20223366 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K102694. 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-0956-2013 · Jan 11, 2013 · Terminated
  Variable Angle Locking Compression Plate/VA-LCP Dorsal Distal Radius Plate, Part Number 02.115.431. Indicated for: Dorsally displaced fractures, Open joint reconstruction, and Cor