EXETER 0939-0-114Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540167231), received between Feb 21, 2017 and Jan 15, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K173499, K191414, K980843); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 15, 2018Packaging Problem; Packaging Problem

  THE CUSTOMER REPORTED THAT WHAT APPEARED TO BE AN EYELASH WAS FOUND INSIDE THE STERILE PACKAGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7192699 ↗
• MalfunctionFeb 21, 2017Break; Break

  EXETER BONE PLUG SIZE 14 MM BROKE ON INSERTION. PART OF IMPLANT WAS REMOVED AND PART STAYED IN SITU. MEDIUM ARTISAN PLUG WAS USED AS A REPLACEMENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6345645 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K173499, K191414, K980843. One submission often covers many models, so check the product and lot details in each record.

• Z-0314-2022 · Oct 15, 2021 · Open, Classified
  28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-122
• Z-0313-2022 · Oct 15, 2021 · Open, Classified
  28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-028