NA 04.124.412Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982110961), received between Aug 16, 2022 and Jan 28, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Break” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THREE MONTHS POST OP THE PATIENT EXPERIENCED CELLULITIS AND WAS ADVISED NOT TO BEAR WEIGHT AND ELEVATE AND ICE THE LEG. ADVERSE EVENT: INFECTION - SUPERFICIAL.

  Patient problems: Unspecified Infection

  MAUDE report 21253428 ↗
• InjuryNov 22, 2022Break; Break

  IT WAS REPORTED ON (B)(6) 2022 THAT A VA-LCP CURVED CONDYLAR PLATE ORIGINALLY IMPLANTED ON (B)(6) 2022 BROKE. THE PLATE WAS EXPLANTED ON (B)(6) 2022 AND REPLACED WITH A PERIPROSTHETIC PLATE. THERE WERE REPORTED PATIENT CONSEQUENCES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 4.5MM TI VA-LCP CRVD CONDYLAR PLATE/12 HOLE/266MM/RIGHT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 15846010 ↗
• InjuryAug 16, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022 ,THAT A HARDWARE REMOVAL THAT TOOK PLACE AT HOSPITAL - DISTAL FEMUR HARDWARE HAD BROKEN ON A PATIENT. THERE WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED BECAUSE PATIENT'S DISTAL FEMUR HARDWARE BROKE, NECESSITATING REMOVAL, EXTERNAL FIXATION, AND PLANNED REVISION SURGERY. THERE WAS PATIENT OUTCOME/CONSEQUENCES. PATIENT IS CURRENTLY IN AN EXTERNAL FIXATION AND WILL NEED REVISION OF DISTAL FEMUR. THIS REPORT IS FOR ONE (1) 4.5 TI VA CRVD COND PL/12 HOLE/266/RT THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15232310 ↗

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