NA 04.124.411Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982110947), received between Jun 21, 2021 and Jun 14, 2022 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 14, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SPAIN AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE IMPLANT RUPTURED AND THE PATIENT NEEDED REOPERATION. THIS REPORT INVOLVES ONE (1) 4.5MM TI VA-LCP CRVD CONDYLAR PLATE/10 HOLE/230MM/LEFT. THIS IS REPORT 1 OF 1 FOR (B)(4).

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

  MAUDE report 14686138 ↗
• InjuryJun 21, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A HARDWARE REMOVAL AND CONVERSION TO DISTAL FEMORAL REPLACEMENT ON (B)(6) 2021. THE PRODUCTS REMOVED WERE (1) TITANIUM VA VARIABLE ANGLE (VA) CONDYLAR DISTAL FEMORAL PLATE AND (1) BROKEN TITANIUM 4.5 CORTEX SCREW. THE LOCKING THREADS ON THE DISTAL END OF THE PLATE APPEAR TO HAVE FAILED (NO LONGER THERE). THE VARIABLE ANGLE (VA) LOCKING SCREWS WERE INTACT AND NOT AFFECTED BUT THEY WERE NO LONGER ENGAGED WITH THE PLATE. THE PATIENT WAS INITIALLY IMPLANTED ON (B)(6) 2021. THE SURGERY WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME IS REPORTED AS DOING WELL. THIS REPORT IS FOR (1) 4.5MM TI VA-LCP CRVD CONDYLAR PLATE/10 HOLE/230MM/LEFT. THIS REPORT IS 2 OF 2 FOR (B)(4).

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

  MAUDE report 12033657 ↗

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