NA 02.118.532Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982039385), received between Jan 16, 2018 and Jan 25, 2021 — classified as 2 injuries.

1 other recall cover devices cleared under the same FDA submission (K120070, K120717, K120854); 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 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2020 THE IMPLANTS WERE REMOVED.

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

  MAUDE report 11225140 ↗
• InjuryJan 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION OF A 1 PLATE, 4 CORTEX SCREW. FOUR (4) VARIABLE ANGLE LOCKING COMPRESSION SCREW AND 1 METAPHYSEAL SCREW ON (B)(6) 2017 DUE TO RIGHT TIBIAL INFECTION. THE PLATE AND SCREWS WERE ORIGINALLY IMPLANTED ON AN UNKNOWN DATE. THE DEVICES WERE REMOVED INTACT AND AN ANTIBIOTIC NAIL WAS IMPLANTED. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO DELAY. THE PATIENT OUTCOME WAS REPORTED AS FINE. THE PATIENT MAY BE SCHEDULED FOR ADDITIONAL SURGERIES AS PART OF A STAGED RE-IMPLANTATION. THIS COMPLAINT IS FOR TEN (10) DEVICES. THIS REPORT IS 10 OF 10 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 7195218 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K120070, K120717, K120854. One submission often covers many models, so check the product and lot details in each record.

• Z-0124-2016 · Sep 28, 2015 · Terminated
  Synthes 2.7MM/3.5MM VA-LCP Medial Distal Humerus Plates 10H/RT/186mm- Sterile and Synthes 2.7MM/3.5MM VA-LCP Extended Medial Distal Humerus Plates 10H/RT/189mm-Sterile The Synthes