GMRS 6495-5-215Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327033700), received between Aug 1, 2023 and Aug 1, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Loss of Osseointegration” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K022403, K023087, K222056, K241716); 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.

• InjuryAug 1, 2023Loss of Osseointegration; Loss of Osseointegration

  THIS PI IS FOR THE FIRST STAGE REVISION ON (B)(6) 2020. 1ST STAGE REVISION - LEFT DISTAL FEMUR PROSTHESIS + SPACER APPLICATION DUE TO ASEPTIC LOOSENING OF DISTAL FEMUR STEM. STABLE PROXIMAL TIBIAL PROSTHESIS. 2ND STAGE REVISION OCCURRED ON (B)(6) 2020 - NO GROWTH WITH TISSUE AND SWAB CULTURE WHICH WAS SENT FROM 1ST STAGE REVISION.

  Patient problems: Inadequate Osseointegration

  MAUDE report 17438994 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K022403, K023087, K222056, K241716. One submission often covers many models, so check the product and lot details in each record.

• Z-2732-2024 · Aug 5, 2024 · Open, Classified
  Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific); Catalog Number: C-MM100434-00;
• Z-2624-2010 · May 5, 2005 · Terminated
  GMRS Extension Piece, 60 mm; Sterile Stryker Howmedica Osteonics; Howmedica Internation S. de. R.L. Limerick, Ireland. The Global Modular Replacement System is intended to be used