GMRS 6495-1-002Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327048711), received between Dec 4, 2017 and Sep 20, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Packaging Problem” (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.

• MalfunctionSep 20, 2018Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  THE INTERNAL PACKAGE WAS PERFORATED AND THE STERILITY OF THE IMPLANT WAS COMPROMISED. THE IMPLANT WAS UNUSABLE. UPDATE 27/AUG/2018: PRIMARY PROCEDURE. SURGICAL DELAY OF 3 MINUTES TO OBTAIN A STANDARD FEMORAL COMPONENT (CAT 6495-1-001).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7893518 ↗
• MalfunctionDec 4, 2017Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT, DURING A SURGERY, WHEN A NURSE PEELED A TYVEK SHEET, OF THE OUTER BLISTER PACK, SALES STAFF FOUND THE CRACK ON THE OUTER BLISTER PACK, THE INNER BLISTER HAD NO DAMAGE SO THE SURGEON DECIDED TO USE THE COMPONENT AS IS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7081372 ↗

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