NA 02.231.218Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982062017), received between Apr 14, 2023 and Apr 14, 2023 — classified as 1 injury.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryApr 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020 THE PATIENT HAD A FALL AND SUSTAINED A PERIPROSTHETIC FEMUR FRACTURE REQUIRING OPEN REDUCTION INTERNAL FIXATION (ORIF). THE PLATE AND SCREWS WERE MANUFACTURED BY SYNTHES. IMPLANTS DID NOT APPEAR TO BE REMOVED. ON (B)(6) 2021 X-RAY TAKEN SHOWED PERSISTENT DISPLACEMENT OF A PARTIALLY HEALED DISTAL FEMUR FRACTURE WITH LATERAL PLATE AND SCREW CONSTRUCT STABLE IN POSITION. ON (B)(6) 2021 INJECTION TO LEFT KNEE FOR PAIN PERFORMED. PAIN HAS PERSISTED DESPITE PHYSICAL THERAPY, BRACING, AND NERVE BLOCKS. ON (B)(6) 2021: SURGEON STATED THAT THE LEFT KNEE IS LIGAMENTOUSLY LOOSE TO VARUS STRESS AND PAIN ON (B)(6) 2021 X-RAY RESULTS STATED THAT THERE IS A PERIPROSTHETIC FRACTURE IN THE DISTAL FEMORAL DIAPHYSIS THAT IS SUBACUTE TO CHRONIC. THERE IS ONE SHAFT WIDTH POSTERIOR DISPLACEMENT OF THE DISTAL FRACTURE FRAGMENT. THERE IS NO EVIDENCE OF HARDWARE FRACTURE OR LOOSENING. SURGEON STATES LEFT KNEE IS UNSTABLE LIKELY SECONDARY TO MALUNION OF THE FEMUR FRACTURE WITH RESULTANT SHORTENING. ON (B)(6) 2021: PATIENT SUSTAINED TWO FALLS RESULTING IN A PELVIC AND THEN A RIGHT HUMERAL FRACTURE. MEDICAL RECORDS DO NOT INCLUDE THE PRIMARY OPERATIVE NOTES, NOR THE REVISIO

  Patient problems: Bone Fracture(s); Malunion of Bone; Pain

  MAUDE report 16747868 ↗

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