NA 02.231.248Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982062161), received between Jan 11, 2024 and Jan 11, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

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

• InjuryJan 11, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN BELGIUM AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY ON (B)(6) 2023, FAILURE OF THE PPFX (PERIPROSTHETIC PROXIMAL FEMUR PLATING SYSTEM) WAS REPORTED BY THE SURGEON. A REVISION PROCEDURE WAS PLANNED. THIS REPORT INVOLVES ONE 5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/48MM. THIS IS REPORT 5 OF 7 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18490893 ↗
• InjuryJan 11, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN BELGIUM AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY ON (B)(6) 2023, FAILURE OF THE PPFX (PERIPROSTHETIC PROXIMAL FEMUR PLATING SYSTEM) WAS REPORTED BY THE SURGEON. A REVISION PROCEDURE WAS PLANNED. THIS REPORT INVOLVES ONE 5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/48MM. THIS IS REPORT 4 OF 7 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18490886 ↗

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