NA 04.124.410Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982110923), received between Apr 11, 2023 and Apr 11, 2023 — 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 (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.

• InjuryApr 11, 2023Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A FEMALE PATIENT UNFORTUNATELY FELL INJURING HER RIGHT FEMUR. ON (B)(6) 2021 THE PATIENT UNDERWENT OPEN REDUCTION AND INTERNAL FIXATION, RIGHT SUPRACONDYLAR PERIPROSTHETIC FEMUR FRACTURE AND IMPLANTABLE BONE STIMULATOR PLACEMENT. ON (B)(6) 2021, THE PATIENT UNDERWENT REVISION OPEN REDUCTION INTERNAL FIXATION RIGHT SUPRACONDYLAR PERIPROSTHETIC FEMUR FRACTURE, PLACEMENT OF IMPLANTABLE BONE STIMULATOR, PLACEMENT OF ALLOGRAFT BONE DUE TO REFRACTURE OF RIGHT FEMUR AND INTERNAL HARDWARE FRACTURE. SHE HAS A DELAYED UNION AND FELT SIGNIFICANT PAIN IN HER LEFT THIGH. THIS REPORT IS FOR A 4.5MM TI VA-LCP CRVD CONDYLAR PLATE/10H/230MM/RIGHT. THIS IS REPORT 1 OF 10 FOR (B)(4).

  Patient problems: Fall; Nonunion/Delayed-union Bone Fracture; Pain

  MAUDE report 16712899 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under 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