VA-LCP 02.124.410SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982042828), received between May 21, 2020 and May 21, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (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.

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.

• InjuryMay 21, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REMOVAL OF 1 4.5MM VARIABLE ANGLE-LOCKING COMPRESSION PLATE CURVED CONDYLAR PLATE RIGHT 10 HOLES, 9 SCREWS AND REVISION OF A INTRAMEDULLARY NAIL, RIGHT FEMORAL SHAFT FRACTURE DUE TO BROKEN PLATE, WHICH CAUSED PAIN AND DIFFICULTY IN WALKING. ON (B)(6) 2019, THE PATIENT UNDERWENT AN OPEN REDUCTION AND INTERNAL FIXATION ON THE RIGHT DISTAL FEMUR. THE PATIENT HAD FALLEN ON THE FLOOR, HEARD A SNAP AND FELT IMMEDIATE SEVERE PAIN IN HER RIGHT THIGH AND WAS UNABLE TO GET HERSELF OFF THE FLOOR. THE PATIENT WAS THEN BROUGHT TO THE EMERGENCY DEPARTMENT. THE FRACTURE WAS STABILIZED USING 4.5MM VARIABLE ANGLE-LOCKING COMPRESSION PLATE CURVED CONDYLAR PLATE RIGHT 10 HOLES AND 9 SCREWS. THE PATIENT WAS SEEN BY PT AND OT DAILY. THE HOSPITAL COURSE WAS UNCOMPLICATED, AND THE PATIENT REMAINED IN STABLE CONDITION. THE PATIENT WAS PRESCRIBED WITH PAIN MEDICATIONS AND COLD THERAPY. THE PATIENT WAS DISCHARGED WITH HOME HEALTH CARE AND PHYSICAL THERAPY. ON (B)(6) 2019, THE PATIENT FOLLOWED UP WITH THE PHYSICIAN DUE TO INCREASED PAIN AND IT WAS FOUND THAT THE (1) 4.5MM VARIABLE ANGLE-LOCKING COMPRESSION PLATE CURVED CONDYLAR PLATE RIGHT 10 HOLES W

  Patient problems: Ambulation or Postural Difficulties; Bone Fracture(s); No Code Available; Pain

  MAUDE report 10078768 ↗

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 · Terminated
  Synthes 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 · Terminated
  Synthes 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