NA 02.231.246Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982062154), received between Mar 19, 2021 and Sep 16, 2022 — classified as 2 injuries.

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.

• InjurySep 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022 ALL IMPLANTS REMOVED WITHOUT INCIDENT. PATIENT WAS INFECTED. CLEAN OUT CANAL THROUGH REAMING AND IRRIGATION. IMPLANT OF AN ANTIBIOTIC COATED NAIL. NO IMPLANTS TO BE RETURNED. THIS REPORT IS FOR ONE (1)5.0 VA LOCKNG SCR SLF-TPNG/SD/46 THIS IS REPORT 10 OF 11 FOR COMPLAINT.

  Patient problems: Unspecified Infection

  MAUDE report 15442400 ↗
• InjuryMar 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021 THE PATIENT UNDERWENT REVISION DUE TO MALUNION OF DISTAL FEMUR. THERE WAS NO SURGICAL DELAY REPORTED. THERE WERE FRAGMENTS GENERATED AND IT IS UNKNOWN IF THEY REMOVE EASILY WITHOUT ADDITIONAL INTERVENTION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR (1) 5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/46MM. THIS REPORT IS 3 OF 10 (B)(4).

  Patient problems: Malunion of Bone

  MAUDE report 11528549 ↗

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