VA-LCP 02.124.408SRecalls & reported problems
Synthes GmbH · 4.5MM VA-LCP CURVED CONDYLAR PLATE/8HOLE/195MM/RT-STER · Class 2 · Implant
All models of VA-LCP (256)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982042781), received between Jan 8, 2025 and Apr 21, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (1 report).
2 other recalls cover devices cleared under the same FDA submission (K083025, K110354); 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.
Reports received per month
Most reported problems
Device problems
- Device-Device Incompatibility1
- No Apparent Adverse Event1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 21, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT DURING A DISTAL FEMUR PROCEDURE ON AN UNKNOWN DATE, AN 8H R PLATE WAS USED. AFTER REDUCTION WAS FINALIZED, SCREWS WERE INSERTED. THE CENTRAL LOCKING DISTAL HOLE SCREW WAS INSERTED AND THE SCREW DID NOT LOCK. UNSURE WHY IT DID NOT LOCK, THEY USED A PERIARTICULAR CLAMP IN THE HOLE. A DENTAL PICK WAS ALSO BENT AND TWO RATCHETING DRIVERS SCREWDRIVER SHAFTS WERE STUCK IN THE SCREWDRIVER HANDLES. NO SURGICAL DELAY WAS REPORTED. THERE WAS NO PATIENT CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21875007 ↗MalfunctionJan 8, 2025No Apparent Adverse Event; No Apparent Adverse Event
THE DEVICE WAS RECEIVED FOR ANALYSIS. THERE WAS NO PRODUCT MALFUNCTION OR PATIENT HARM REPORTED WITH THE RETURNED DEVICE. UPON INSPECTION, IT WAS NOTED TO BE BROKEN.
Patient problems: Insufficient Information
MAUDE report 21101803 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K083025, K110354. One submission often covers many models, so check the product and lot details in each record.
- Z-1125-2014 · Feb 5, 2014 · TerminatedSynthes 5.0mm Variable Locking Screw This device is part of the Variable Angle Locking Compression Plate family and this technology included variable angle Combi holes in the plat
- Z-0401-2014 · May 29, 2013 · TerminatedSynthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER is used for buttressing multi fragmentary diatal femur fra
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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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