VA-LCP 04.111.521Recalls & reported problems
Synthes GmbH · 2.4MM TI VA-LCP 2-COL DSTL RAD PL NRW 6H HD/2H SHAFT/LT · Class 2 · Implant
All models of VA-LCP (256)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982101563), received between Feb 2, 2017 and Feb 2, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fitting Problem” (1 report).
1 other recall cover devices cleared under the same FDA submission (K092556); 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
Device problems
- Fitting Problem1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 2, 2017Fitting Problem; Fitting Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT SURGERY ON (B)(6) 2017 FOR A LEFT DISTAL RADIUS FRACTURE. IT WAS DESCRIBED THAT THE SURGEON IMPLANTED THE FIRST FOUR SCREWS WITHOUT INCIDENT BUT AS HE WAS INSERTING THE 5TH SCREW INTO THE MOST DISTAL ULNA SCREW HOLE OF THE 2.4MM VARIABLE ANGLE LOCKING COMPRESSION PLATE (LCP), TWO COLUMN DISTAL RADIUS PLATE, THE LOCKING MECHANISM ON THE PLATE FAILED. AS A RESULT, THE SURGEON HAD TO REMOVE THE FIVE IMPLANTED 2.4MM VARIABLE ANGLE LOCKING SCREWS AND THE PLATE. THE PLATE WAS REPLACED WITH THE SAME TYPE OF PLATE AND THE SURGEON REPLANTED THE FIRST FIVE SCREWS AND ADDED A SIXTH SCREW. THERE WAS A 15 TO 20 MINUTE DELAY IN THE SURGERY DUE TO THE ISSUE. IT WAS REPORTED THAT THE SURGERY WAS COMPLETED SUCCESSFULLY AND THE PATIENT WAS STABLE. THIS COMPLAINT IS FOR ONE DEVICE. CONCOMITANT DEVICE: 2.4MM VARIABLE ANGLE LOCKING SCREW (PART #UNKNOWN, LOT #UNKNOWN, QUANTITY 1). THIS REPORT IS 1 OF 1 FOR COM-(B)(4).
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6297975 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K092556. One submission often covers many models, so check the product and lot details in each record.
- Z-2057-2013 · May 31, 2013 · TerminatedSynthes 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
Other Screw, fixation, bone devices
- NA 03.043.029Synthes GmbH · Screw, fixation, bone503 reports
- OSTEORAPTOR 72201995Smith & Nephew, Inc. · Screw, fixation, bone253 reports
- Control 360 SK12Treace Medical Concepts, Inc. · Screw, Fixation, Bone195 reports
- HEALIX PEEK ORTHOCORD 222205Medos International Sàrl · Screw, fixation, bone186 reports
- PRECICE® Bone Transport System STP3.5-400Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-225Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-350Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-300Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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