NA 02.210.094Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982052759), received between Apr 2, 2018 and Apr 2, 2018 — classified as 1 injury.

4 other recalls cover devices cleared under the same FDA submission (K092556, 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 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.

• InjuryApr 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A HARDWARE REMOVAL AND REVISION SURGERY WAS PERFORMED ON (B)(6) 2018. THE INITIAL SURGERY WAS PERFORMED ON (B)(6) 2018 FOR AN OPEN REDUCTION AND INTERNAL FIXATION OF THE DISTAL RADIUS. THE HARDWARE REMOVAL WAS DUE TO TWO (2) 2.7 MM PROXIMAL CORTICAL SCREWS BACKING OUT OF THE BONE. DURING THE SURGERY THERE WAS A LOT OF FLUID IN THE WOUND INDICATING A POSSIBLE INFECTION. FIVE CULTURES WERE TAKEN TO SEE IF AN INFECTION IS PRESENT BUT RESULTS ARE NOT YET AVAILABLE. THE HARDWARE THAT WAS REMOVED WAS ONE (1) 2.4 MM VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA-LCP) 2 COLUMN VOLAR DISTAL RADIUS PLATE, FIVE (5) 1.8 MM BUTTRESS SCREWS, ONE (1) 2.4 MM CORTICAL LOCKING SCREW, AND TWO (2) 2.7 MM CORTICAL SCREWS. ALL PARTS WERE INTACT WITH NO MALFUNCTIONS. PATIENT WAS REVISED TO A DORSAL SPANNING PLATE AND SIX (6) 2.7 MM LOCKING SCREWS. THERE WERE NO SURGICAL DELAYS, X-RAYS ARE NOT AVAILABLE, SURGERY WAS COMPLETED SUCCESSFULLY AND PATIENT OUTCOME WAS STABLE. THIS REPORT IS FOR ONE (1) 1.8 MM VA LOCKING BUTTRESS PIN. THIS IS REPORT 9 OF 9 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 7390263 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K092556, 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-2057-2013 · May 31, 2013 · Terminated
  Synthes 2.4mm VA-LCP Two Column Volar Distal Radius Plate and Torque limiting attachment, 1.2Nm Synthes VA-LCP Distal Radius System is intended for fixation of complex intra- and
• 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