NA 02.231.230Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982062079), received between Aug 25, 2020 and Apr 11, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, THE MEDICAL RECORDS RECEIVED ON (B)(6) 2022, THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) DISTAL FEMUR FRACTURE DUE TO RIGHT PERIPROSTHETIC DISTAL FEMUR FRACTURE. ON (B)(6) 2022 THE PATIENT HAD A REVISION DUE TO NONUNION RIGHT DISTAL FEMUR SHAFT FRACTURE ABOUT TOTAL KNEE ARTHROPLASTY (TKA). THIS REPORT IS FOR ONE (1) 5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/30MM. THIS IS REPORT 7 OF 11 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 16718051 ↗
• MalfunctionAug 25, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DEVICES WERE DISCOVERED AS DAMAGED AFTER THE SALES CONSULTANT RECEIVED THE ITEM SHIPMENTS. MULTIPLE PACKAGES WERE BROKEN WITH THE SCREWS REPORTED AS FLATTENED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 5.0MM VARIABLE ANGLE LOCKING SCREW/SLF-TPNG/STRDRV/30MM. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10448776 ↗

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