GMRS 6495-6-070Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327049206), received between Feb 14, 2020 and Sep 9, 2026 — classified as 2 injuries.

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

2 other recalls cover devices cleared under the same FDA submission (K023087, K222056, K233261, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 9, 2026Degraded

  It was reported that the patient presented with poly failure and wear as well as apparent metallosis of GMRS taper junctions which was noticed upon patella fracture treatment.

  Patient problems: Foreign Body Reaction

  MAUDE report 50690351 ↗
• InjuryFeb 14, 2020Fracture; Fracture

  PATIENT FRACTURE GETS EXTENSION BODY. UPDATE: "THIS WAS A LEFT FEMUR. THE FAILURE OCCURRED ON THE EXTENSION BODY AT THE JUNCTION OF THE TAPER AS YOU CAN SEE IN THESE IMAGES."

  Patient problems: Injury

  MAUDE report 9711029 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K023087, K222056, K233261, 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