Adapter Sleeve 6519-T-204Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540608406), received between Sep 29, 2017 and Sep 29, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K070885, K173499, K243784); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2017Device Operates Differently Than Expected; Adverse Event Without Identified Device or Use Problem; Device Operates Differently Than Expected; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING A THA, THE TRUNNION SLEEVE DID NOT FIT COMPLETELY (THERE WAS A GAP) ON THE STEM TRUNNION (CITATION STEM).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6903193 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K070885, K173499, K243784. One submission often covers many models, so check the product and lot details in each record.

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