GMRS 6495-5-219Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327033748), received between May 7, 2026 and May 7, 2026 — classified as 1 injury.

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.

• InjuryMay 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER AN INTRA-OPERATIVE FRACTURE OF THE PATIENT'S LEFT FEMUR ONE DAY PRIOR, THE PATIENT WAS BROUGHT BACK (AS PLANNED) AND A COMPETITOR PLATE WAS IMPLANTED. NO IMPLANTS WERE REMOVED. CASE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Periprosthetic fracture

  MAUDE report 25109740 ↗

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